MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker field service representative (fsr) evaluated the customer's device and was able to verify and duplicate the reported issue.Stryker's fsr disassembled the rear case, refitted the battery pin to the washer and the battery terminal nuts were tightened.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Event or Problem Description
The customer contacted stryker to report that a battery pin of their device had been pushed in, with the result that the battery could not be inserted into the well.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 that a battery pin of their device had been pushed in, with the result that the battery could not be inserted into the well.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
Section h11, additional mfg narrative of the initial medwatch report indicates: "a stryker field service representative (fsr) evaluated the customer's device and was able to verify and duplicate the reported issue.Stryker's fsr disassembled the rear case, refitted the battery pin to the washer and the battery terminal nuts were tightened.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer." section h11, additional mfg narrative of the initial medwatch report should indicate: "a stryker field service representative (fsr) evaluated the customer's device and was able to verify and duplicate the reported issue.Stryker's fsr disassembled the rear case, refitted the battery pin into the washer and the battery terminal nuts were tightened to resolve the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.The root cause of the reported issue was determined to be loose battery pins/ connector cable to power pcb assembly.".

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 19179954
• Report Number: 0003015876-2024-01269
• Device Sequence Number: 6989199
• Product Code: MKJ
• UDI-Device Identifier: 00883873871621
• UDI-Public: 00883873871621
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 08/22/2024

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: 15
• Device Catalogue Number: 99577-001964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2016
• 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