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

Model Number 20E

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted physio-control to report that their device provided insufficient energy when delivering defibrillation therapy into a simulator.As a result, adequate defibrillation may not be available, if it was needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control evaluated the customer's device and was unable to duplicate or verify the reported issue.After performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The root cause of the reported issue was unable to be determined.

Event Description

A customer contacted physio-control to report that their device provided insufficient energy when delivering defibrillation therapy into a simulator.As a result, adequate defibrillation may not be available, if it was needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: 8824250
• MDR Text Key: 152189662
• Report Number: 0003015876-2019-01257
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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: 99507-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1