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

Model Number 20E

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the device would not charge or discharge shock.Physical damage to the device's case was observed.Physio will replace the device's user interface board to resolve the issue.After observing proper device operation through functional and performance testing, the device will be 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.During testing by physio-control, the device would not charge or deliver shock.

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.During testing by physio-control, the device would not charge or deliver shock.

Manufacturer Narrative

Physio-control determined that the cause of the reported issue was due to the therapy board.The customer requested that the device be returned without repair.Therefore, no parts were replaced and the device was returned to the customer.

• Brand Name: LIFEPAK 20E 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: 11168688
• MDR Text Key: 226770807
• Report Number: 0003015876-2021-00112
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873813805
• UDI-Public: 00883873813805
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2020
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1