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	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
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 does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.This issue is patient related; however, there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to verify or duplicate the reported issue.The device was able to power on under ac power.The was unable to power under dc power, however this was due to a depleted battery.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be conclusively determined.Correction: section a1 of the initial medwatch report (mfr report #0003015876-2023-01776) indicates: patient identifier: none.Section a1 of the initial medwatch report (mfr report #0003015876-2023-01776) should indicate: patient identifier: blank.Section b5 of the initial medwatch report (mfr report #0003015876-2023-01776) indicates: executive summary: the customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.Section b5 of the initial medwatch report (mfr report #0003015876-2023-01776) should indicate: executive summary: the customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.This issue is patient related; however, there was no adverse patient outcome reported.Section h6 of the initial medwatch report (mfr report #0003015876-2023-01776) indicates: health impact code grid; no patient involvement.Section h6 of the initial medwatch report (mfr report #0003015876-2023-01776) should indicate: health impact code grid: no health consequences or impact.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17832275
• Report Number: 0003015876-2023-01776
• Device Sequence Number: 6890491
• Product Code: MKJ
• UDI-Device Identifier: 00883873852804
• UDI-Public: 00883873852804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/30/2024

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: 99507-000132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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