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

Model Number	20
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was provided with a loaner device.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 intermittently displayed a blank screen.In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
Additional Manufacturer Narrative
The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.H3 other text : device not returned to manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device intermittently displayed a blank screen.In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient use reported with the 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: 9604357
• Report Number: 0003015876-2020-00099
• Device Sequence Number: 19377977
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/02/2020

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: 99402-000065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1