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

Device Problems Inadequate Instructions for Healthcare Professional (1319); Use of Device Problem (1670)

Patient Problems Atrial Fibrillation (1729); Ventricular Fibrillation (2130)

Event Date 12/06/2022

Event Type  Injury  

Event Description

Pt was shocked at 360 j synced for cardioversion due to afib after tee performed.Remained afib after 1st shock.2nd shock at 360 j delivered.Unsynced and pt converted to vfib.Code started and rosc obtained.Monitor returned to unsynced mode after 1st shock delivered.Due to user error manufacturer rep notified and educated team on sync/unsync settings.

• Type of Device: LIFEPAK 15 MONITOR / DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARAB
• Manufacturer (Section D): STRYKER / PHYSIO-CONTROL, INC.; 2825 airview blvd,; portage, MI 49002
• MDR Report Key: 16086082
• MDR Text Key: 306658913
• Report Number: MW5114127
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White