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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the reported issue.Physio-control also observed that the device was delivering monophasic energy rather than biphasic energy.The energy delivered by the device was also at a lower energy level than what was selected.Physio-control 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 Description

The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio found that a service indicator is present and an event code is logged in the memory of their device.The event code logged in its memory 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

Physio-control replaced the device's bi-phasic pcb assembly to resolve the reported issue.Further evaluation of the removed bi-phasic pcb assembly determined that the cause of the reported issue was shorted transistors q5 and q6.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio found that a service indicator is present and an event code is logged in the memory of their device.The event code logged in its memory 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 15 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10770000
• MDR Text Key: 214110362
• Report Number: 0003015876-2020-01616
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 99577-001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1