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

Model Number	20
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control evaluated the customers device and was unable to duplicate the reported issue.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 displayed a solid green screen and was "not able to provide therapy shock".This issue is patient related; however there was no adverse patient outcome reported.A second device was used and the patient survived the event.
Event or Problem Description
The customer contacted physio-control to report that their device displayed a solid green screen and was "not able to provide therapy shock".This issue is patient related; however there was no adverse patient outcome reported.A second device was used and the patient survived the event.
Additional Manufacturer Narrative
This submission was found to be a duplicate of mfr# 0003015876-2020-00443.Please reference this record for all investigation details.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9881315
• Report Number: 0003015876-2020-00424
• Device Sequence Number: 19560653
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/06/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1