Complete the Confirmation Sheet, and return it to Physio-Control using the information on the form.

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1 LIFEPAK 15 Monitor/Defibrillators RECALL (2/17) Reason/Information: Physio-Control, Inc. issued an Urgent Medical Device Correction on the following materiel(s). The FDA classified this recall as a Class I on 11 February Reason: The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA). Disposition/Instructions: Positive acknowledgement of product on hand requires the reporting of actions via the Patient Safety Reporting System (PSRS). Using the Patient Safety Reporting System (PSRS), the affected MTF patient care area should report all events where the recalled product was available in the facility. The Number of Times Occurred (NOTO) should not be used to report events where the recalled product reached the patient, but can be used for near misses, e.g. the product was on the shelf. In the "Event Description" field in PSRS, annotate the MMQC number (MMQC-YY-XXXX) and relevant facts related to the recall. If the product is a medical device, annotate the Work Order # in the PSRS "Actions Taken" field. Questions should be forwarded to the Clinical Performance Assurance Directorate (CPAD) Patient Safety Program via usarmy.jbsa.medcom.list.medcom-psc@mail.mil. Actions to be taken: Complete the Confirmation Sheet, and return it to Physio-Control using the information on the form. Perform the "User Test" every day, as instructed in the operating instructions on page If the device fails the "User Test," immediately contact Physio-Control to arrange for product correction, which will include replacement of the therapy PCBA. Continue to perform the "User Test" as outlined in the Daily Operator's Checklist in the operation instructions. Inform all relevant personnel at your facility of the information in the letter, and forward a copy of the letter to any facility to which you have further distributed affected product. For Further Information: Physio-Control technical support department Tel.: (800) (select option 7), 6 a.m. to 4 p.m. Pacific time, Monday through Friday Note: See Image on Message under Additional Documentation/Attachment for enclosed referenced document(s) and manufacturer letter.

2 Item Information: NSN (FSC-NIIN): Nomenclature: UI: Manufacturer: NS1 LIFEPAK 15 MONITOR/DEFIBRILLATOR EA PHYSIO-CONTROL, INC. Distributor: LOT / SN:

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5 URGENT MEDICAL DEVICE CORRECTION ACTION REQUIRED LIFEPAK 15 Monitor/Defibrillator URGENT Please bring this letter to the immediate attention of the person(s) responsible for maintaining/monitoring your LIFEPAK 15 Monitor/Defibrillators. January 2017 Dear Valued Customer, This communication is a notification to specific owners of the LIFEPAK 15 devices. This notification affects 338 devices and provides critical information regarding the readiness of your device. Physio-Control will be conducting a voluntary Field Correction of these LIFEPAK 15 devices. The attached Confirmation Sheet includes the list of potentially affected device serial numbers that we show in your possession and are impacted by this Field Correction. Description of Issue Physio-Control has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA). A malfunction of the Relay can be identified during the User Test of the device, as described in the chapter titled Maintaining the Equipment within the LIFEPAK 15 Operating Instructions (refer to the excerpt from the Operating Instructions on page 2 of this notification). If the User Test fails, the device will illuminate the Service indicator on the device. Please contact Physio-Control immediately to schedule the device correction. If the User Test passes, the device is safe to use. Continue to perform the daily device self-tests as indicated in the Operating Instructions. Physio-Control s Planned Actions Physio-Control is contacting customers with LIFEPAK 15 devices that contain the potentially affected Relay component to arrange for a device correction of all 338 devices. This correction will include the replacement of the Therapy PCBA. Required Customer Actions 1. Please forward this letter to all of your sites, trainers and users that have an affected LIFEPAK 15 device as identified on the attached Confirmation Sheet. 2. Follow the instructions on the Confirmation Sheet for each serial number listed in your possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If the device fails the User Test, as described above, contact Physio-Control immediately to arrange for correction of your device. 4. Continue to perform the User Test as outlined in the Daily Operator s Checklist within the LIFEPAK 15 Operating Instructions. Should you have any questions about this subject, please contact us at , option 7, 6:00 A.M. to 4:00 P.M. (PST), Monday Friday. Sincerely, Rod J. Rylands Vice President, Quality PHYSIO-CONTROL, INC. Page 1

6 Excerpt from LIFEPAK 15 Operating Instructions User Tests The User Test is a functional test of the LIFEPAK 15 monitor/defibrillator. The User Test should be performed only as a test and not while using the defibrillator during patient care. Perform the User Test as a part of completing the daily Operator s Checklist. Note: The defibrillator must be in Manual mode to perform the User Test. To perform a User Test separate from completing the Operator s Checklist: 1. Press ON to turn on the LIFEPAK 15 monitor/defibrillator. 2. Press OPTIONS. The Options menu appears. 3. Select USER TEST. The defibrillator performs the following tasks: Self-tests to check the device. Charges to 10 joules and discharges internally (this energy is not accessible at the therapy connector). Prints a Pass/Fail report. If the LIFEPAK 15 monitor/defibrillator detects a failure during the User Test, the Service LED is illuminated and the printed report indicates that the test failed. Remove the defibrillator from use and contact a qualified service technician. If you must interrupt the User Test, turn the power off and then on again. The test stops and the defibrillator operates normally. A Pass/Fail report does not print. Page 2