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

Model Number 20E

Device Problem Failure to Charge (1085)

Patient Problem Chest Pain (1776)

Event Date 09/05/2022

Event Type  Death  

Manufacturer Narrative

The customer provided stryker with all the available patient information.Patient fields in which information was not provided were intentionally left blank.Stryker performed a clinical review of the reported event and determined that the device use may have contributed to the patient's outcome as the patient presented with a shockable rhythm, but defibrillation therapy was delayed.Stryker 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 stryker to report that they were using their device during a patient event and the attempted to charge the device to deliver defibrillation therapy; however, the device failed to charge.The users attempted to charge the device again and this time it worked and they were able to deliver multiple shocks to the patient.The patient involved in the reported event is deceased.

Event Description

The customer contacted stryker to report that they were using their device during a patient event and the attempted to charge the device to deliver defibrillation therapy; however, the device failed to charge.The users attempted to charge the device again and this time it worked and they were able to deliver multiple shocks to the patient.The patient involved in the reported event is deceased.

Manufacturer Narrative

Stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.

• 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: 15543667
• MDR Text Key: 301182957
• Report Number: 0003015876-2022-02207
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White