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

Model Number	15
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device's service indicator is present and there is an event code logged in the device's memory.The event code logged in the device's memory can indicate that the aed function of the device may be inoperable.As a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode, if it was necessary.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.The cause of the issue was not established.The technician determined the monitor was unserviceable due to it's failure to pace.The device was left with the customer unrepaired.
Event or Problem Description
The customer contacted stryker to report that their device's service indicator is present and there is an event code logged in the device's memory.The event code logged in the device's memory can indicate that the aed function of the device may be inoperable.As a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode, if it was necessary.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Section h6 results code of the initial medwatch report indicates: electrical problem identified.

• 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: 19316289
• Report Number: 0003015876-2024-01597
• Device Sequence Number: 12346835
• Product Code: MKJ
• UDI-Device Identifier: 00883873905609
• UDI-Public: 00883873905609
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/23/2024

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: 99577-001275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2015
• 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