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	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker service representative performed an evaluation of the customer¿s device and observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.The event code was cleared from the memory of the device and thereafter did not return.Thereafter proper device operation through functional and performance testing.The device was returned to the loaner pool.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Section b5, executive summary of the initial medwatch report indicates: the customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient use associated with the reported event.Section b5, executive summary of the initial medwatch report should indicate: the customer contacted stryker to report a non-critical issue with a loaner device, belonging to stryker.Upon inspection, stryker observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient use associated with the reported event.Section h11, executive summary of the initial medwatch report indicates: a stryker service representative performed an evaluation of the customer¿s device and observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.The event code was cleared from the memory of the device and thereafter did not return.Thereafter proper device operation through functional and performance testing.The device was returned to the loaner pool.The cause of the reported issue could not be conclusively determined.Section h11, executive summary of the initial medwatch report should indicate: a stryker service representative performed an evaluation of the loaner¿s device and observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.The event code was cleared from the memory of the device and thereafter did not return.Thereafter proper device operation through functional and performance testing.The device was returned to the stryker loaner pool.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient use associated with the reported 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18701002
• Report Number: 0003015876-2024-00319
• Device Sequence Number: 6195288
• Product Code: MKJ
• UDI-Device Identifier: 00883873877081
• UDI-Public: 00883873877081
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 06/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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