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

Model Number	15
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.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 after a shock their device showed "abnormal shock detected" message.The customer also reported that two event codes were logged in the memory of their device.The first event code logged in its memory indicates 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.The second even code logged in its memory is related to a potential failure of the device to deliver defibrillation energy.In this state the device would be inoperable and defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issues.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.Stryker further evaluated the replaced part at the product analysis center (pac).The pac technician found h-bridge component q8 to be shorted.The root cause of the reported issue was determined to be a shorted transistor, q8.The faulty pcb assembly was archived by stryker.Per the operating instructions for the lifepak 15 device, "possible damage to defibrillator and defibrillator shutdown.When two defibrillators are used to deliver energy to the same patient at the same time, one or both defibrillators may be damaged and shutdown may occur.If the defibrillator shuts down, take the defibrillator out of service and contact qualified service personnel".
Event or Problem Description
The customer contacted stryker to report that after a shock their device showed "abnormal shock detected" message.The customer also reported that two event codes were logged in the memory of their device.The first event code logged in its memory indicates 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.The second even code logged in its memory is related to a potential failure of the device to deliver defibrillation energy.In this state the device would be inoperable and defibrillation therapy would not be available, if needed.There were no reports of adverse effects to the patient as a result of the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 18382479
• Report Number: 0003015876-2023-02481
• Device Sequence Number: 18042617
• Product Code: MKJ
• UDI-Device Identifier: 00883873871799
• UDI-Public: 00883873871799
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/23/2024

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: 99577-001947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2018
• 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 Sex: Unknown