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 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

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 that their device generated an error message that abnormal energy was delivered.There was no patient involvement reported with the event.

Manufacturer Narrative

Physio-control evaluated the customer's device and verified the reported issue.Through a review of the device's electronic logs physio found evidence of use error causing damage to the device.No parts were replaced.The customer declined repairs and the device was returned to customer unrepaired.The customer was advised not to use the unit until repairs are done.

Event Description

The customer contacted physio-control to report that their device generated an error message that abnormal energy was delivered.There was no patient involvement reported with the event.

• 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: 11532566
• MDR Text Key: 241471413
• Report Number: 0003015876-2021-00614
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 03/22/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1