MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 1000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank. 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 gave incorrect shock advisory in aed mode during intervention on a patient.The device indicated normal sinus rhythm but a shock was advised.In this state, wrong defibrillation therapy may be delivered.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: LIFEPAK(R) 1000 DEFIBRILLATOR
• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19114029
• MDR Text Key: 340916485
• Report Number: 0003015876-2024-00804
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873815465
• UDI-Public: 00883873815465
• 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
• Report Date: 04/16/2024

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: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000025
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2022
• 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