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

Model Number	20
Medical Device Problem Codes	Failure to Power Up (1476); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control performed an initial evaluation of the customers device and was unable to duplicate the reported issue.During the evaluation physio observed the device fail to provide audio prompts.Physio-control continues to investigate the reported failure 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 not booting up at all.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
Event or Problem Description
The customer contacted physio-control to report that their device was not booting up at all.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
Additional Manufacturer Narrative
Physio replaced the device's system and user interface pcb assemblies as a precaution.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluate the removed system and user interface pcb assemblies and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.

• 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: 9958209
• Report Number: 0003015876-2020-00509
• Device Sequence Number: 19524220
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 99402-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1