MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device will not complete boot-up cycle during power up.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Event or Problem Description
The customer contacted stryker to report that their device will not complete boot-up cycle during power up.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-02442) indicates: stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-02442) should indicate: stryker evaluated the customers device and was able to verify and duplicate the reported issue.The cause of the reported issue was isolated to the battery, and replaced to resolve the issue.The device passed functional and performance testing and was returned to the customer for use.

• Brand Name: LIFEPAK® 1000 DEFIBRILLATOR
• 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: 18374648
• Report Number: 0003015876-2023-02442
• Device Sequence Number: 7710853
• Product Code: MKJ
• UDI-Device Identifier: 00883873815465
• UDI-Public: 00883873815465
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• 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): 04/30/2024

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: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2006
• 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