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 Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device failed to deliver a shock.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.The electronic records of the device were downloaded for further investigation.Proper device operation was observed through functional and performance testing and the device was, subsequently, returned to the customer for use.The electronic records of the device were reviewed by stryker product analysis center (pac).The electronic record for the event date shows that the device did not detect the qrs complex in order to deliver defibrillation therapy.The lp15 monitor/defibrillator operating instruction, synchronized cardioversion procedure states "observe the ecg rhythm and confirm that the sense marker appears near the middle of each qrs complex.".The pac technician found no issue with the device.Therefore, the root cause of the reported issue was traced to training.
Event or Problem Description
The customer contacted stryker to report that their device failed to deliver a shock.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• 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: 19115254
• Report Number: 0003015876-2024-00831
• Device Sequence Number: 12537585
• Product Code: MKJ
• UDI-Device Identifier: 00883873871676
• UDI-Public: 00883873871676
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 99577-001959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2018
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG