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	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2020
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 service indicator was illuminated.Upon evaluation of the customer's device, physio-control observed that the device was delivering a monophasic energy output instead of a biphasic output.As a result, the incorrect defibrillation therapy may be delivered.There was no patient use associated with this event.
Event or Problem Description
The customer contacted physio-control to report that their device service indicator was illuminated.Upon evaluation of the customer's device, physio-control observed that the device was delivering a monophasic energy output instead of a biphasic output.As a result, the incorrect defibrillation therapy may be delivered.There was no patient use associated with this event.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the therapy pcb assembly to resolve the reported issue.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Further root cause could not be determined.

• 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: 9883243
• Report Number: 0003015876-2020-00436
• Device Sequence Number: 19518185
• Product Code: MKJ
• UDI-Device Identifier: 00883873813782
• UDI-Public: 00883873813782
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 99402-000067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1