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 Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the therapy pcb assembly to resolve this issue.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device failed the user test.Upon evaluation of the customer's device, physio-control observed that an event code logged in the device's memory that is related to a potential failure of the device to deliver defibrillation energy.Physio also observed another 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 it were necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the removed therapy pcb assembly and determined the cause of the reported issue was due to transistor, designator q7.Q7 had become electrically shorted.

Event Description

The customer contacted physio-control to report that their device failed the user test.Upon evaluation of the customer's device, physio-control observed that an event code logged in the device's memory that is related to a potential failure of the device to deliver defibrillation energy.Physio also observed another 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 it were necessary.There was no patient use associated with the reported event.

• 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
• MDR Report Key: 10324130
• MDR Text Key: 200439038
• Report Number: 0003015876-2020-00949
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871713
• UDI-Public: 00883873871713
• 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: 08/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1