MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to physio control.A third-party service agent evaluated the customer's device and verified the reported issue.After replacing the therapy pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.

Event Description

The customer contacted physio-control to report that their device had illuminated its service led and logged an event code into its memory that's 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.  the defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.  there was no report of patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the removed therapy pcb assembly and found the reported issue was due to transistor, designator q27.Pin 5 to 9 were shorted in diode, designator cr30, which was caused by burning from transistor, designator q26.The purpose of transistor, designator q27 is to aid in the turn off of cr30 which should lead to the device shut off after energy is delivered.The issue with transistor, designator q27 resulted in an initial shock being biphasic, but further shocks being monophasic and less energy when tested on a mock-up device, in either a defibrillation shock or during a user test.Device delivered shock, then turned off.The root cause of the reported issue was identified as transistor, designator q27.

Event Description

The customer contacted physio-control to report that their device had illuminated its service led and logged an event code into its memory that's 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.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no report of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20 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: 9521261
• MDR Text Key: 189991574
• Report Number: 0003015876-2019-02073
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: 20
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1