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

Model Number	1000
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that the battery of their device was leaking in the device.As a result, device may have been inoperable and defibrillation therapy would not be available, 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
A customer contacted stryker to report that the battery of their device was leaking in the device.As a result, device may have been inoperable and defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 15759494
• Report Number: 0003015876-2022-02454
• Device Sequence Number: 6226627
• Product Code: MKJ
• UDI-Device Identifier: 00883873919477
• UDI-Public: 00883873919477
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160026
• 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): 04/25/2023

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: 11141-000156
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BATTERY.
• Patient Sex: Unknown