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

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker field service representative (fsr) performed an initial evaluation of the customer's device and was able to verify the reported issue but was unable to duplicate it.The stryker fsr observed that the battery pins were worn.Therefore, the battery pins were replaced.The stryker fsr has determined that the system pcb needs to be replaced to resolve the reported issue.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that their device would not complete the boot cycle during initial power-up.In addition, the customer noticed that the device would no longer turn on.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device would not complete the boot cycle during initial power-up.In addition, the customer noticed that the device would no longer turn on.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Corrected data: section h11, additional mfg narrative of the initial medwatch report indicates "the stryker fsr has determined that the system pcb needs to be replaced to resolve the reported issue."; section h11, additional mfg narrative of the initial medwatch report should indicate "the stryker fsr has determined that the system pcb needs to be replaced as a precautionary measure".Section h6, investigation findings, results code grid (1) of the initial medwatch report indicates "electrical problem identified", conclusion code fda "120"; section h6, investigation findings, results code grid (1) of the initial medwatch report should indicate "operational problem identified", conclusion code fda "114".Section h6, investigation conclusions, conclusion code grid (1) of the initial medwatch report indicates "cause traced to component failure", conclusion code fda "4307"; section h6, investigation conclusions, conclusion code grid (1) of the initial medwatch report should indicate "conclusion not yet available", conclusion code fda "11".Additional information: the stryker fsr (field service representative) replaced the system pcb assembly as a precautionary measure.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Stryker further evaluated the removed system pcb assembly, in the product analysis center (pac), and the pac technician was not able to duplicate the reported issue.The system pcba passed all functional tests.It was determined that the root cause of the reported issue could not be established.

• 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: 18684371
• Report Number: 0003015876-2024-00301
• Device Sequence Number: 6509265
• Product Code: MKJ
• UDI-Device Identifier: 00883873871805
• UDI-Public: 00883873871805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/01/2024

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: 99577-001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2016
• 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