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 Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of 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 a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed an event code logged in the device's memory.The event code logged in the device's memory is related to a failure of the device to deliver defibrillation energy.As a result, defibrillation therapy may be unavailable, if needed.
Additional Manufacturer Narrative
Stryker replaced the device's system pcb and power pcb assemblies.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Stryker further evaluated the removed pcb assemblies and was unable to duplicate the reported issue.A root cause for the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed an event code logged in the device's memory.The event code logged in the device's memory is related to a failure of the device to deliver defibrillation energy.As a result, defibrillation therapy may be unavailable, if needed.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 13343354
• Report Number: 0003015876-2022-00092
• Device Sequence Number: 19852162
• Product Code: MKJ
• UDI-Device Identifier: 00883873871836
• UDI-Public: 00883873871836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/31/2022

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: 99577-001943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2017
• 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