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	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed 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 deliver defibrillation therapy, if needed.There was no report of patient harm associated with the reported event.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.  a stryker service representative performed an initial evaluation of the customer¿s device and observed that their device had logged an event code in the memory which is related to a potential issue of the device deliver energy.After clearing the codes, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Additional Manufacturer Narrative
The electronic records were downloaded for review.The reported issue was able to be verified but not duplicated.The lp15 v4 software version -110 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 and 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.The root cause of the reported issue is determined to be software coding.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed 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 deliver defibrillation therapy, if needed.There was no report of patient harm associated with the reported event.

• 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: 18657024
• Report Number: 0003015876-2024-00280
• Device Sequence Number: 7316911
• Product Code: MKJ
• UDI-Device Identifier: 00883873884331
• UDI-Public: 00883873884331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/15/2024

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: 99577-001373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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