MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 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 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Stryker evaluated the customer's device and verified the reported issue.After replacing the system pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A customer contacted stryker to report that their electrode cable was not recognized when connected to the device.As a result, defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Event Description

A customer contacted stryker to report that their electrode cable was not recognized when connected to the device.As a result, defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker product assessment center (pac) further evaluated the customer's device and determined that the cause of the reported issue was due to an inoperative integrated circuit, u61, on the system pcb assembly.

• 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
• 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: 16358017
• MDR Text Key: 309332642
• Report Number: 0003015876-2023-00256
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: 99507-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2020
• 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