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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC.; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC.; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number L496166461
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 04/14/2022
Event Type  Injury  
Event Description
Cardiologist note, the defibrillator was set on sync mode for the first two cardioversions.Review of the third cardioversion indicated the shock was delivered on the t-wave despite being set on the sync mode.Biomedical engineering inspected the defibrillator and said it seemed to be working.Biomedical engineer recommended contacting the physiocontrol company to inspect the function of the defibrillator.The lifepak defibrillator has been taken out of service.The company representative has been called to inspect functions and settings of the equipment.
 
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Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC.
11811 willows rd ne
redmond WA 98052
MDR Report Key14618962
MDR Text Key293449029
Report Number14618962
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/23/2022
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
Device Catalogue NumberL496166461
Device Lot Number20210802
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/23/2022
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer06/07/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Life Threatening;
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