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

Model Number 15

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate Waveform (2536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker performed an initial evaluation of the customer¿s device and verified the reported issue.Stryker isolated the issue to the therapy pcb assembly.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted stryker to report that their device displays "abnormal energy delivery message." in this state, wrong defibrillation therapy may be delivered to the patient.There was no patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the customer¿s device was unable to deliver defibrillation energy.In addition, the device logged an event code 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 it were necessary.

Manufacturer Narrative

Stryker further evaluated the customer's device and replaced the therapy pcb assembly.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Stryker further evaluated the removed therapy pcb assembly.It was observed that transistor, designator q8 was electrically shorted.

Event Description

The customer contacted stryker to report that their device displays "abnormal energy delivery message." in this state, wrong defibrillation therapy may be delivered to the patient.There was no patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the customer¿s device was unable to deliver defibrillation energy.In addition, the device logged an event code 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 it were necessary.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: 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: 13483244
• MDR Text Key: 285686292
• Report Number: 0003015876-2022-00184
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871805
• UDI-Public: 00883873871805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1