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

Model Number	15
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0003015876-2023-01952
• Device Sequence Number: 6726118
• Product Code: MKJ
• UDI-Device Identifier: 00883873911556
• UDI-Public: 00883873911556
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown