MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	20
Medical Device Problem Codes	Energy Output Problem (1431); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the device and verified the reported issue; the device would not turn on.Physio found the user interface flex cable and printer flex cable not connected to user interface pcba.Additionally, the printer flex cable and ecg cable were routed incorrectly.After the cables were re-routed and flex cables connected, the device would turn on.However, it was then observed that it would not deliver energy properly; it delivered monophasic therapy rather than biphasic and displayed 'abnormal energy delivery' on the screen.It was observed that the filter, designator fl8, on the therapy pcba was broken.It was determined that the device would need a replacement therapy pcba as well as repairs unrelated to the reported issue.The power (not turning on) issue was found to be caused by the user interface-to-stack flex cable assembly.The issue delivering monophasic shock and the 'abnormal energy' message were found to be related to the therapy pcba.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted physio-control to report that they cannot turn on their device.In this state the device would not be able to deliver defibrillation therapy if needed.Additionally, after repairs it was found that the unit was not delivering energy properly, which could also prevent proper defibrillation therapy.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and determined that component fl8 was damaged by the customer's misrouting of the wire harness.
Event or Problem Description
The customer contacted physio-control to report that they cannot turn on their device.In this state the device would not be able to deliver defibrillation therapy if needed.Additionally, after repairs it was found that the unit was not delivering energy properly, which could also prevent proper defibrillation therapy.There was no report of patient use associated with the reported event.

• Brand Name: LIFEPAK 20 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: 10597683
• Report Number: 0003015876-2020-01342
• Device Sequence Number: 19127158
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 20
• Device Catalogue Number: 99402-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1