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 Deliver Energy (1211); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issues.Physio replaced the device's therapy pcb assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device was delivering the wrong level of defibrillation energy during testing.As a result, the wrong defibrillation therapy may be delivered to a patient, if needed.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed event codes logged in the device's memory.One event code logged is indicative of a failure of the device to deliver defibrillation energy.The other event code is indicative of the device delivering a monophasic shock.
Additional Manufacturer Narrative
Stryker further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to a shorted transistor, designator q7.
Event or Problem Description
The customer contacted physio-control to report that their device was delivering the wrong level of defibrillation energy during testing.As a result, the wrong defibrillation therapy may be delivered to a patient, if needed.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed event codes logged in the device's memory.One event code logged is indicative of a failure of the device to deliver defibrillation energy.The other event code is indicative of the device delivering a monophasic shock.

• 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: 12632424
• Report Number: 0003015876-2021-01973
• Device Sequence Number: 14315590
• Product Code: MKJ
• UDI-Device Identifier: 00883873871782
• UDI-Public: 00883873871782
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 01/06/2022

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: 99577-001948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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 Sex: Unknown