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

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the reported issue.Physio found broken pieces of the device's therapy pcb assembly inside the bottom case, damage to the j2 capacitor connector, and damage to the front and top cases.The therapy pcb assembly, capacitor connector, front and top cases were replaced to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation by physio-control it was found that the device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation by physio-control it was found that the device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.

Manufacturer Narrative

Although the customer initially reported their device was functional, physio-control found that the customer's device was unable to deliver energy in the reported condition.Physio-control further evaluated the removed therapy pcb assembly found diodes cr43 and cr44 were shorted.Physio determined that the cause of the reported issue was likely shorted diode cr44.

• Brand Name: LIFEPAK 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: 10715051
• MDR Text Key: 212467714
• Report Number: 0003015876-2020-01560
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• 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: 11/10/2020

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: 99402-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1