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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.A stryker service representative performed an evaluation of the customer¿s device and was not able to duplicate the reported issue.The electronic records were downloaded for review and the reported issue was verified.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device had unexpectedly lost power.In this state the device may not be able to deliver defibrillation therapy, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
Event or Problem Description
The customer contacted stryker to report that their device had unexpectedly lost power.In this state the device may not be able to deliver defibrillation therapy, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
Section a, age, gender and weight of the initial medwatch report indicates blank.Section a, age, gender and weight of the initial medwatch report should indicate 80, f, 104.Section h11, additional mfg narrative of the initial medwatch report indicates stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.A stryker service representative performed an evaluation of the customer¿s device and was not able to duplicate the reported issue.The electronic records were downloaded for review and the reported issue was verified.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A cause of the reported issue could not be determined.Section h11, additional mfg narrative of the initial medwatch report should indicate stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.A stryker service representative performed an evaluation of the customer¿s device and was not able to duplicate the reported issue.The electronic records were downloaded for review and the reported issue was verified.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A cause of the reported issue could not be determined.

• 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: 20301520
• Report Number: 0003015876-2024-02723
• Device Sequence Number: 8686754
• Product Code: MKJ
• UDI-Device Identifier: 00883873871690
• UDI-Public: 00883873871690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 01/28/2025

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: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 104 KG