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

Model Number	15
Medical Device Problem Codes	Failure to Power Up (1476); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device was unable to be powered on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified 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 was unable to be powered on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Correction from initial mfr number 0003015876-2023-01289.H10 indicates: stryker evaluated the customer's device and verified the reported issue.H10 should indicate: stryker evaluated the customer's device and was unable to verify the reported issue.The device worked as intended and powered up properly with both ac and battery power.Additionally, error code a034 was observed in the device's memory logs, which is related to a potential issue of the device to deliver energy.The event code was cleared from the memory of the device and thereafter did not return.After observing proper device operation through functional and performance testing the device was returned to the customer for use.The root cause for the reported issues were not able to be determined.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17349131
• Report Number: 0003015876-2023-01289
• Device Sequence Number: 5290098
• Product Code: MKJ
• UDI-Device Identifier: 00883873871638
• UDI-Public: 00883873871638
• 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): 08/16/2023

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: 99577-001963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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