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

Model Number 15

Device Problem Electrical Power Problem (2925)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The customer has been provided with a repair quote however the device has not been returned for evaluation.The cause of the reported issue can not be determined.

Event Description

The customer contacted stryker to report their device does not boot up into normal operation mode.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.

• Brand Name: LIFEPAK® 15 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18926801
• MDR Text Key: 337952427
• Report Number: 0003015876-2024-00574
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873912782
• UDI-Public: 00883873912782
• 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
• Report Date: 03/18/2024

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: 99577-001218
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2011
• 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