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	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer informed stryker that no further patient information is available.Patient fields in which information was not provided were intentionally left blank.Stryker evaluated the customer's device and verified the reported issue.Stryker replaced the device's therapy pcb assembly to resolve the reported issues.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report that their device displayed an "abnormal energy delivered" message during a patient event.As a result, the wrong defibrillation therapy may have been delivered to the patient, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Upon evaluation of the customer's device, stryker observed an event code logged in the device's memory that is related to a potential failure of the device to deliver defibrillation energy.There was also an event code logged in the device's memory that is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if necessary.
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 q8.
Event or Problem Description
The customer contacted stryker to report that their device displayed an "abnormal energy delivered" message during a patient event.As a result, the wrong defibrillation therapy may have been delivered to the patient, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Upon evaluation of the customer's device, stryker observed an event code logged in the device's memory that is related to a potential failure of the device to deliver defibrillation energy.There was also an event code logged in the device's memory that is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if necessary.

• 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: 14000909
• Report Number: 0003015876-2022-00499
• Device Sequence Number: 14781603
• Product Code: MKJ
• UDI-Device Identifier: 00883873871805
• UDI-Public: 00883873871805
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/03/2022

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: 99577-001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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