MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 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	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.Stryker 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 stryker to report that their device intermittently did not power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.
Event or Problem Description
The customer contacted stryker to report that their device intermittently did not power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.
Additional Manufacturer Narrative
Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-00746) indicates: a stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.Stryker 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.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-00746) should indicate: stryker 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.Section h6 method code grid of the initial medwatch report (mfr report #0003015876-2023-00746) indicates: testing of actual/suspected device.Section h6 method code grid of the initial medwatch report (mfr report #0003015876-2023-00746) should indicate: type of investigation not yet determined.The device was not returned to stryker for further evaluation.Stryker provided the customer with a repair quote; however, the customer did not request any follow-up and will proceed with the recommended repair/evaluation at their discretion.The cause of the reported issue could not be determined.Device not returned.

• Brand Name: LIFEPAK® 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16811439
• Report Number: 0003015876-2023-00746
• Device Sequence Number: 17668578
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 06/20/2023

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: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown