BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCANNING TABLE

    MDR report key: 5881 · Received June 25, 1993

    Report

    Report Number
    2126677-1993-00005
    Event Type
    Death
    Date Received
    June 25, 1993
    Date of Event
    April 28, 1993
    Report Date
    May 13, 1993
    Manufacturer
    ADC MEDICAL
    Product Code
    IYZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT WHILE A TECHNICIAN WAS MOVING A NUCLEAR MEDICINE SCANNING TABLE, WITH A PATIENT ON IT, A WHEEL CAME OFF OF THE TABLE. THE PATIENT REPORTEDLY SLID FROM THE TABLE TO THE FLOOR AND HIT HER HEAD. SHE RECEIVED A BRUISE AND A SMALL CUT ON HER FOREHEAD. X-RAYS WERE TAKEN OF HER SKULL AND HIP. A DOCTOR EXAMINED HER. NO TREATMENT WAS GIVEN FOR THE CUT ON THE FOREHEAD. IT WAS ALSO REPORTED TO GE THAT THE PATIENT DIED SOME 16 HOURS LATER. WE HAVE NO INFORMATION ABOUT THE PATIENT'S PRE-EXISTING CONDITION AND OUR INVESTIGATION HAS NOT PRODUCED ANY INFORMATION ABOUT CAUSE AND EFFECT. AT THIS TIME WE CONSIDER THE FALL AND THE SUBSEQUENT DEATH TO BE UNRELATEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANNING TABLE NUCLEAR MECHINE SCANNING TABLE IYZ ADC MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death