MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customers device and verified the reported issue.It was found that the battery power level was low, causing the device to power off.After unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Physio determined that use error was the cause of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device powered off multiple times unexpectedly.In this state the device may not be able to deliver defibrillation therapy if needed.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Physio-control further evaluated the device data and identified that the battery being utilized when the device powered off had a state of charge below 50% and was almost three years old (physio recommends that customers replace batteries every two years according to lifepak 15 operating instructions.Old, compromised batteries contribute to an increased resistance on the input power path, which can result in an excessive voltage drop when high current functions such as code summary printing are activated.The excessive voltage drop triggers the power fail detector circuit on the power board which in turn will cause the device to shut down or power cycle.Therefore, the root cause of the reported issue was an old battery.
Event or Problem Description
The customer contacted physio-control to report that their device powered off multiple times unexpectedly.In this state the device may not be able to deliver defibrillation therapy if needed.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9158901
• Report Number: 0003015876-2019-01662
• Device Sequence Number: 16682243
• Product Code: MKJ
• UDI-Device Identifier: 00883873911556
• UDI-Public: 00883873911556
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1