BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIAC CX

    MDR report key: 92301 · Received May 12, 1997

    Report

    Report Number
    92301
    Event Type
    Other
    Date Received
    May 12, 1997
    Date of Event
    April 8, 1997
    Report Date
    April 21, 1997
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    ITY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    44 YEAR OLD MALE UNDERGOING A RADIOFREQUENCY ABLATION. THE C-ARM BOLT SNAPPED. THE C-ARM WENT FROM AN AP PROJECTION TO A LATERAL POSITION. THE PT RECEIVED NO INJURIES. THE PROCEDURE WAS ABORTED, THE PT'S HEART WAS PACED OUT OF ATRIAL FLUTTER INTO NORMAL SINUS RHYTHM, HE REMAINED IN NORMAL SINUS RHYTHM AND WAS DISCHARGED TO HOME THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC CX RADIOGRAPHIC EQUIPMENT ITY FISCHER IMAGING CORP. 620010 62001G *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other