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

Model Number 20E

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  Death  

Manufacturer Narrative

Stryker performed an initial evaluation of the customer's device and was unable to duplicate or verify the reported issue.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 their device gave the message "connect electrodes" while in use with a patient.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.Another device was used to deliver therapy.

Event Description

The customer contacted stryker to report that their device gave the message "connect electrodes" while in use with a patient.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.Another device was used to deliver therapy.

Manufacturer Narrative

The device was returned to stryker for further investigation.The reported issue was unable to be verified and unable to be duplicated.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.Corrected information: the initial medwatch report h10 and/or h11 should indicate: the customer provided stryker with the available patient information.

• 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: 16542055
• MDR Text Key: 311285813
• Report Number: 0003015876-2023-00473
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873852804
• UDI-Public: 00883873852804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• 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: 05/25/2023

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: 99507-000132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2019
• 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 Sex: Female
• Patient Race: Black Or African American