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

Model Number	20
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control performed an initial evaluation of the customer¿s device and verified the reported issue.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 their device was able to complete a boot up cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Section h10/h11 of the initial medwatch report indicates: additional mfg narrative ¿ the customer contacted physio-control to report that their device was able to complete a boot up cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.Section h10/h11 of the initial medwatch report should indicate: additional mfg narrative ¿ the customer contacted physio-control to report that their device service indicator was illuminated.Upon arrival at the customer site, physio-control was made aware by the customer that their staff biomed attempted to repair their device by replacing the coin cell battery.After the coin cell battery was replaced and the device reassembled, the device was unable to complete a boot cycle upon powering on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.Additional information: physio-control replaced the system controller pcb assembly to resolve the reported issue.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 further evaluated the removed system controller pcb assembly and observed filter, designator fl3 was physically broken causing an open circuit.Physio determined that the damaged component was the result of the maintenance performed on the device.
Event or Problem Description
The customer contacted physio-control to report that their device was able to complete a boot up cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: 10018675
• Report Number: 0003015876-2020-00590
• Device Sequence Number: 2089315
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 04/22/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1