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

Model Number 20

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control performed an initial evaluation of the customer's device and verified the reported issue.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 a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device delivered a monophasic shock at 23.4 joules at a selected energy level of 200 joules.As a result, the wrong defibrillation therapy may be delivered to a patient, if it is needed.

Manufacturer Narrative

Physio-control replaced the device's therapy pcb assembly to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to a cracked filter, designator fl29.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device delivered a monophasic shock at 23.4 joules at a selected energy level of 200 joules.As a result, the wrong defibrillation therapy may be delivered to a patient, if it is needed.

• 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: 9211601
• MDR Text Key: 190687825
• Report Number: 0003015876-2019-01709
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873813744
• UDI-Public: 00883873813744
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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: 99402-000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1