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

Model Number 20E

Device Problem Sparking (2595)

Patient Problem Ventricular Fibrillation (2130)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.(b)(4).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 following defibrillation the pad sparked and the patient exhibited burns and peeling of the skin on their chest.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Stryker evaluated the customer's device and could not verify or duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Root cause could not be determined.

Event Description

The customer contacted physio-control to report that following defibrillation the pad sparked and the patient exhibited burns and peeling of the skin on their chest.This issue is patient related; however there was no adverse event reported.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12586980
• MDR Text Key: 275175666
• Report Number: 0003015876-2021-01917
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873887660
• UDI-Public: 00883873887660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 20E
• Device Catalogue Number: 99507-000106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ELECTRODES,CAT 11996-000017,LOT 115155,EX 10/28/23
• Patient Age: 75 YR
• Patient Sex: Male