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

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Physio-control evaluated the customers device and was unable to duplicate or verify the reported issue.Physio-control replaced the devices main keypad assembly as a precaution.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device was being used during a code on a patient (no patient information available) when caregivers attempted to deliver a shock at 360joules.Upon pushing the shock button, nothing happened per report.Caregivers powered the device off and on, then utilized the device again and it performed properly.Caregivers delivered appropriate shock to patient and was successfully resuscitated.Upon evaluation of the customer's device, the customer observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.The issue is patient related and was reported to have delayed defibrillation for an unknown time.

• 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
• MDR Report Key: 12291664
• Report Number: 0003015876-2021-01541
• Device Sequence Number: 11545904
• Product Code: MKJ
• UDI-Device Identifier: 00883873911600
• UDI-Public: 00883873911600
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other