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 09/26/2023

Event Type  malfunction  

Event Description

The customer contacted stryker to report that their device would unexpectedly reboot during routine inspection.In this state defibrillation therapy may be delayed if needed.There was no patient involvement reported with the event.

Manufacturer Narrative

Stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.Inspection found the battery pins had a slight deformation and were replaced.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Manufacturer Narrative

The initial medwatch report additional mfg narrative/h11 indicated: stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.Inspection found the battery pins had a slight deformation and were replaced.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The initial medwatch report additional mfg narrative/h11 should have indicated: stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.Inspection found the battery pins had a slight deformation and were replaced.Further inspection of the device and disassembly of the rear case found additional loose nuts on the battery pins.These were tightened to specification.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 would unexpectedly reboot during routine inspection.In this state defibrillation therapy may be delayed 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17993736
• MDR Text Key: 326358745
• Report Number: 0003015876-2023-01952
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911556
• UDI-Public: 00883873911556
• 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: 12/01/2023

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: 15
• Device Catalogue Number: 99577-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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