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

Model Number	1000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation and observed that the battery would not insert into the device.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 a non-critical issue with their device.During evaluation it was found that the battery would not insert into the device.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.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation it was found that the battery would not insert into the device.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.
Additional Manufacturer Narrative
The device was further evaluated by a stryker field service representative (fsr).The fsr verified and duplicated the reported issue.The root cause was traced to a damaged battery lock.The lp1000 was determined to be unrepairable by the fsr.The device was removed from service.

• 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: 19573455
• Report Number: 0003015876-2024-01944
• Device Sequence Number: 19819459
• Product Code: MKJ
• UDI-Device Identifier: 00883873815458
• UDI-Public: 00883873815458
• 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): 10/24/2024

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: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2013
• 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