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

Model Number	20E
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer evaluated their device and isolated the issue to the power module assembly.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.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The third party service agent replaced the power module pcb assembly.And then after observing proper device operation through functional and performance testing, the device was returned to the customer for use.

• Brand Name: LIFEPAK(R) 20E 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: 11318977
• Report Number: 0003015876-2021-00384
• Device Sequence Number: 3443359
• Product Code: MKJ
• UDI-Device Identifier: 00883873813751
• UDI-Public: 00883873813751
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2021

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: 20E
• Device Catalogue Number: 99507-000001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 08/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1