URGENT RECALL FOR PRODUCT CORRECTION HeartSine Technologies samaritan PAD 500P (Public Access Defibrillator) Software upgrade

Transcription

1 URGENT RECALL FOR PRODUCT CORRECTION HeartSine Technlgies samaritan PAD 500P (Public Access Defibrillatr) Sftware upgrade TGA Reference Number: RC-2014-RN Dear Owners f the samaritan PAD 500P, The purpse f this letter is t infrm yu f a crrective actin that HeartSine Technlgies Ltd. is intrducing in relatin t samaritan PAD 500P public access defibrillatrs. The crrective actin is intended t address an issue that culd affect the accuracy f the CPR (cardipulmnary resuscitatin) instructins prvided t rescuers by the samaritan PAD 500P during a sudden cardiac arrest situatin. HeartSine Technlgies recrds indicate that yu have received a samaritan PAD 500P device which is affected by this actin. Issue identified The samaritan PAD 500P is intended, where apprpriate, t deliver shcks t victims f a sudden cardiac arrest and has a secndary functin t prvide feedback t rescuers cncerning the effectiveness f the CPR they are prviding. The crrective actin described in this Urgent Recall fr Prduct Crrectin relates t this secndary functin. The sftware in yur samaritan PAD 500P may miscalculate the CPR rate f cmpressin per minute being administered t the patient. The rescuer may, therefre, be incrrectly advised by the device t Push Slwer when, in fact, the CPR rate is at an acceptable level. There are reprts f death and serius injury during the use f the samaritan PAD 500P devices, and in tw cases the incrrect CPR feedback given t the user cannt be eliminated as being a cntributry factr t the patient utcme. Any samaritan PAD 500P devices manufactured between February 2010 and January 2014 with the fllwing serial numbers inclusive are affected by this issue: 10B t 14B

2 Crrective actin related t the samaritan PAD 500P T address the issue described in this Field Safety Ntice, an updated versin f the sftware (3.4.0) fr the samaritan PAD 500P is nw available. The updated sftware has been psted n the HeartSine Technlgies website ready fr dwnlad. If yu already have a HeartSine data cable and internet access, please fllw the instructins in Annex I f this Recall fr Prduct Crrectin and fill ut the respnse card in Annex II. If yu d nt have a HeartSine data cable r internet access, yu shuld ask Aer Healthcare, using the Respnse Card in Annex II, t send yu an upgrade kit. When yu receive the upgrade kit, fllw the instructins prvided, in rder t upgrade yur device sftware. D nt remve the device frm service. If yu have any questins, please call Aer Healthcare at If yu have further distributed yur samaritan PAD 500P, please ntify yur custmers at nce f this cmmunicatin. Please als prvide Aer Healthcare with the custmer's cntact infrmatin s that we can fllw-up with the current wner f the device. This actin has been undertaken after cnsultatin with the Therapeutic Gds Administratin (TGA) We appreciate yur understanding as we wrk t ensure that we are prviding yu with the mst up t date and reliable devices yu have cme t trust. Sincerely, Tim Ovenden Managing Directr Aer Healthcare

3 ANNEX I Upgrade Instructins If yu have a HeartSine data cable and access t the internet yu can execute the upgrade immediately. 1. G t 2. Click n the link PAD 500P Upgrader User Instructins t dwnlad the instructins t yur desktp. 3. Fllw the instructins t cmplete the sftware dwnlad. 4. On cmpletin f each device upgrade return the upgrade certificate t Aer Healthcare via web uplad, r pst as per the n screen instructins. t: data@aerhealthcare.cm Pst t: Aer Healthcare 63 Seatn Street Armidale NSW 2350 Australia Fax t: Insert the User Manual update (see Annex lll) int the riginally supplied User Manual, stred in the sft carry case f the samaritan PAD 500P. 6. Fill ut the respnse card in Annex II. It is critical that yu return the upgrade certificate as it enables HeartSine Technlgies Ltd. t update its recrds fr yur device and cnfirms that the upgrade has been successfully carried ut.

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5 ANNEX II Respnse Card Please assist us in making this crrective actin prcess efficient and cnvenient fr yu by cmpleting and returning this Respnse Card t Aer Healthcare via mail, , r fax. This card serves as a cnfirmatin that yu have received and understd this ntificatin. Please als indicate the address t which yu wuld like the upgrade kit t be shipped if required. A cver sheet is nt required fr this Respnse Card. ADDRESS: Aer Healthcare 63 Seatn Street Armidale NSW 2350 FAX: data@aerhealthcare.cm If yu have questins, please call Aer Healthcare at between 9:00 am t 5:00 pm Mnday t Friday. Please cmplete this frm by checking the applicable bxes indicating that yu understand and have taken the recmmended actins. We have a HeartSine data cable and internet access. We shall update the device(s) sftware by accessing the relevant HeartSine Technlgies web link. We d NOT have a data cable and/r internet access. Please supply us with a HeartSine data cable and sftware CD. Upn receipt f these we shall update the device(s) sftware using the HeartSine data cable supplied and either the CD supplied r by accessing the relevant HeartSine Technlgies web link. We shall return the upgrade certificate. We shall place the User Manual update with the riginally supplied User Manual. Device serial number(s) Facility Name: Facility Address: Identify where yu wuld like the upgrade kit shipped if different frm abve. Cmpleted By: Title: Signature: Date: Phne: Fax: Preferred frm f Phne Fax cntact Upn receipt f the sftware upgrade certificate we d nt anticipate needing t cntact yu again regarding this actin. We will nt use this infrmatin fr any ther reasn.

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7 Annex III User Manual Update. This sheet cntains updates made after the publicatin f the User Manual fr the samaritan PAD 500P. Prduct Family: HeartSine samaritan PAD 500P Date: 20 th February 2014 Manual: User Manual Please replace the table in Sectin titled ECG Arrhythmia Analysis Algrithm with the table belw Rhythm Class Sample Size (sec.) Required Perfrmance Perfrmance Results (%) 90% One- Sided Lwer Cnfidence Limit Shckable Rhythm: Ventricular Fibrillatin (VF) Shckable Rhythm: Ventricular Tachycardia (VT) Nn-Shckable Rhythm: Cmbined Nn-Shckable Rhythms Nn-Shckable Rhythm: Asystle Sensitivity > 90% Sensitivity > 75% Specificity > 95% Specificity > 95% 100* 99.97* Please replace the table in Sectin titled CPR Advisr Analysis Algrithm with the table belw CPR Criteria CPR speed: gd Perfrmance Specificatins Sensitivity > 90% Specificity > 90% Perfrmance Results (%) CPR frce: adequate Sensitivity > 90% Specificity > 90%