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

Model Number	20
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that the defibrillation energy level delivered from their device was not as expected, when attempted.As a result, wrong defibrillation therapy would be delivered, 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.
Additional Manufacturer Narrative
Section h3, device evaluated by mfg of the initial medwatch report indicates yes.Section h3, device evaluated by mfg of the initial medwatch report should indicate no.Section h3, reason for no evaluation of the initial medwatch report indicates blank.Section h3, reason for no evaluation of the initial medwatch report should indicate device evaluation anticipated but not yet began.A stryker field service representative evaluated the customer's device and verified the reported issue.The device could no longer be repaired due to part obsolescence.The device was returned to the customer unrepaired.
Event or Problem Description
A customer contacted stryker to report that the defibrillation energy level delivered from their device was not as expected, when attempted.As a result, wrong defibrillation therapy would be delivered, if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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
• 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: 18112618
• Report Number: 0003015876-2023-02090
• Device Sequence Number: 18108639
• Product Code: MKJ
• UDI-Device Identifier: 00883873813799
• UDI-Public: 00883873813799
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/05/2024

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: 20
• Device Catalogue Number: 99402-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2005
• 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