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

Model Number	1000
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the device and was able to confirm and duplicate the reported issue.During investigation it was also discovered the will not turn on at all.The device is at end of life and will be scrapped.
Event or Problem Description
The customer contacted stryker to report their device unexpectedly shuts off.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The cause of the reported issue could not be determined.Correction: section a patient identifier of the initial medwatch report indicates: blank.Section a patient identifier of the initial medwatch report should indicate: none.Section b executive summary of the initial medwatch report indicates: this issue is patient related; however, there was no adverse event reported.Section b executive summary of the initial medwatch report should indicate: there was no patient involvement reported with the event.
Event or Problem Description
The customer contacted stryker to report their device unexpectedly shuts off.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.

• 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: 20391793
• Report Number: 0003015876-2024-02831
• Device Sequence Number: 15090270
• Product Code: MKJ
• UDI-Device Identifier: 00883873815458
• UDI-Public: 00883873815458
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122600
• 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): 03/05/2025

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: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2008
• 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