BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIACAM (510(K) K 901019)

    MDR report key: 320395 · Received March 13, 2001

    Report

    Report Number
    1423253-2001-00001
    Event Type
    Other
    Date Received
    March 13, 2001
    Date of Event
    February 13, 2001
    Report Date
    February 14, 2001
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    KPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT JUST COMPLETED A CARDIO-FOCAL SCAN PROCEDURE. THE PT WAS SECURED TO AN OFFSET PALLET WITH A BODY WRAP. THE OFFSET PALLET WAS SECURED TO THE PT HANDLING SYSTEM (PHS) BY VELCRO ATTACHMENTS. AFTER COMPLETION OF SCAN, THE TECH REMOVED THE PT FROM FIELD OF OPERATION. THE TECH REMOVED THE BODY WRAP ALLOWING THE PT FREE ACCESS TO MOVE. THE TECH TURNED AWAY FROM THE PT AND FOCUSED ON THE SYSTEM COMPUTER. THE TECH REPORTED HEARING THE VELCRO THAT HOLDS THE OFFSET PALLET TO PT HANDLING SYSTEM (PHS) PULL AWAY FROM THE BED, AND TURNED AROUND IN TIME TO SEE THE PT SLIDE FROM THE OFFSET PALLET TO THE FLOOR. UPON IMPACT WITH THE FLOOR, THE PT DISLOCATED THEIR RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11182 DIACAM (510(K) K 901019) GAMMA CAMERA KPS SIEMENS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other