MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Unexpected Shutdown (4019)

Patient Problems Anemia (1706); Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Event Description

The customer contacted stryker to report that their device unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.   a stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.

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.   clinical review of the reported event will be performed.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 unexpectedly lost power.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This customer reported that the device may have caused serious injury of the patient.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 18777049
• MDR Text Key: 336305755
• Report Number: 0003015876-2024-00428
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871713
• UDI-Public: 00883873871713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• 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: 04/17/2024

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: 15
• Device Catalogue Number: 99577-001955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 82 KG