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

Model Number 15

Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

The customer contacted stryker to report that their device experienced an unexpected loss of power, additionally their device would not complete its initial boot-up cycle.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no report of patient use associated with the reported event.

Manufacturer Narrative

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.

Manufacturer Narrative

Stryker evaluated the customer's device and was unable to duplicate or verify the reported issue.The battery pins were replaced as a precaution.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.

Event Description

The customer contacted stryker to report that their device experienced an unexpected loss of power, additionally their device would not complete its initial boot-up cycle.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no report of patient use associated with the reported event.

• 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: 17785500
• MDR Text Key: 323912949
• Report Number: 0003015876-2023-01712
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871690
• UDI-Public: 00883873871690
• 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: 04/08/2024

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: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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