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	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device had logged an event code in the memory which indicates that the aed function of the device may be inoperable.In this state the device may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode, if necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and verified the reported issue.Stryker replaced the therapy pcb assembly.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Stryker further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to an electrically shorted capacitor, designator c160.The short caused the capacitor to be leaky, which resulted in no device pacer or aed function.The device was able to deliver therapy in manual mode.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 14015726
• Report Number: 0003015876-2022-00515
• Device Sequence Number: 17282879
• Product Code: MKJ
• UDI-Device Identifier: 00883873911761
• UDI-Public: 00883873911761
• 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
• Report Date (Section B): 04/05/2022

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: 99577-001243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2013
• 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