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

Model Number	20
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to provide any further information for the event or the patient.Patient fields in which information was not provided were intentionally left blank.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 charged to 200j during a code when it twice powered down before it was able to deliver a shock.The clinicians were then able to use another device and deliver therapy successfully.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device but was unable to duplicate or verify the reported issue.Other unrelated issues were observed, however the customer declined to have their device repaired and the device was returned unrepaired to them.The customer was informed not to use the device.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was charged to 200j during a code when it twice powered down before it was able to deliver a shock.The clinicians were then able to use another device and deliver therapy successfully.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.

• 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: 10497471
• Report Number: 0003015876-2020-01183
• Device Sequence Number: 16908029
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2020

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: 08/14/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1