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

Model Number	15
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device failed to show the patient's ecg through the paddles lead even though they had defibrillation electrodes connected to the patient.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
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.Stryker evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Additional Manufacturer Narrative
Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.Stryker also observed that the device had an event code logged in its memory.The event code logged in the device's memory is indicative of a failure of the device to deliver defibrillation energy.The cause of the reported and observed issues could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device failed to show the patient's ecg through the paddles lead even though they had defibrillation electrodes connected to the patient.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 20202165
• Report Number: 0003015876-2024-02620
• Device Sequence Number: 7643517
• Product Code: MKJ
• UDI-Device Identifier: 00883873871690
• UDI-Public: 00883873871690
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/31/2025

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: 08/16/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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