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

Model Number	15
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   physio-control evaluated the customers device and proper device operation was observed through functional and performance testing.Physio-control evaluated the device data and determined the cause of the reported issue was traced to the user.The device was returned to the customer for use.Physio-control performed a clinical review and determined the user failed to follow the operating instructions and confirm that a triangle sense marker appears near the middle of each qrs complex, this caused a serious injury which necessitated medical intervention to preclude permanent impairment.
Event or Problem Description
The customer contacted physio-control to report that when using their device that unit shocked patient into v-fib, unit isn't syncing properly.The patient received a synchronized cardioversion during the vulnerable period of their ecg which caused them to convert to ventricular fibrillation.Defibrillation was required to achieve a return of spontaneous circulation, the patient survived 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
• MDR Report Key: 10541193
• Report Number: 0003015876-2020-01258
• Device Sequence Number: 3161375
• Product Code: MKJ
• UDI-Device Identifier: 00883873872079
• UDI-Public: 00883873872079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2020

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: 99577-001932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/16/2020
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 196