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	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
A customer contacted stryker to report that their device had logged an event code in the memory which is related to a potential issue of the device deliver energy.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Event or Problem Description
A customer contacted stryker to report that their device had logged an event code in the memory which is related to a potential issue of the device deliver energy.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed evaluation of the customer¿s device and was able to verify and duplicate the reported issue.The cause of the reported issue was determined to be due to the customer attempting to run a user test immediately after powering on the device.This is a known issue addressed in technical bulletin (b)(4) rev at section 5.7.The lp15 v4 software version -109 adds an additional h-bridge test when the device is powered on.The same h-bridge test is also performed when the user performs a user test.If a user initiates a user test immediately after turning the device on, the device attempts to perform 2 h-bridge tests at the same time which will cause the user test to fail and the service light to come on.When the user test fails error codes a034 & a036 or a51e is logged in the device.Performing 2 h-bridge tests at the same time does not cause any damage and the device is still operational with the service light lit.When the power is cycled the service light is cleared and the device will pass the user test when initiated a few seconds after power up.After clearing the logged event codes and completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.

• 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: 19616295
• Report Number: 0003015876-2024-01995
• Device Sequence Number: 6018164
• Product Code: MKJ
• UDI-Device Identifier: 00883873871829
• UDI-Public: 00883873871829
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/05/2024

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: 99577-001944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• 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