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

Model Number 20E

Device Problem Unexpected Shutdown (4019)

Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

The customer provided stryker with all the available patient information.Stryker continues to investigate the reported issue 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 powered off during a patient event.The customer advised that the device was able to be powered back on and was used to complete the procedure.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

Manufacturer Narrative

The customer provided stryker with additional patient information.Sections a and b have been updated.Patient fields in which information is not provided or were already submitted, were intentionally left blank.The customer provided the serial number of the device.Appropriate fields in section d and h have been updated.

Event Description

The customer contacted stryker to report that their device powered off during a patient event.The customer advised that the device was able to be powered back on and was used to complete the procedure.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.The patient did die, however it was the result of acute myocardial infarction and not the result of device use.

Manufacturer Narrative

A third party service agent evaluated the customer's device and was able to verify and duplicate the reported issue.It was determined that the cause of the reported issue was due to a depleted battery.The battery was replaced to resolve the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Event Description

The customer contacted stryker to report that their device powered off during a patient event.The customer advised that the device was able to be powered back on and was used to complete the procedure.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.The patient did die, however it was the result of acute myocardial infarction and not the result of device use.

• 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: 16301856
• MDR Text Key: 308894863
• Report Number: 0003015876-2023-00179
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

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: 70507-000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/04/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 04/06/2023
• Supplement Dates FDA Received: 03/22/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG