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

Model Number	15
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and verified the reported issue.Stryker replaced the therapy pcb assembly and then observed proper device operation through functional and performance testing.The device was returned to the customer for use.Stryker further evaluated the removed therapy pcb assembly.It was observed that resistor, designator r2 was making an intermittent solder joint connection, due to a large amount of non-conductive coating of the lead protruding through the solder barrel.When contact was not made, paddles lead would go to dashed lines.Stryker determined that the cause of the reported issue was due to a poor solder joint.
Event or Problem Description
A stryker service representative was performing routine preventative maintenance on the customer¿s device and observed excessive artifact on the paddles lead.In this state, the device may not have the ability to function in aed mode, and defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with this event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 15670507
• Report Number: 0003015876-2022-02354
• Device Sequence Number: 12367418
• Product Code: MKJ
• UDI-Device Identifier: 00883873814185
• UDI-Public: 00883873814185
• 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
• Report Date (Section B): 10/25/2022

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: 99577-000006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2010
• 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