BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGRAPH 64 AND BIOGRAPH 40

    MDR report key: 9976995 · Received April 20, 2020

    Report

    Report Number
    1034973-2020-00001
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    April 9, 2020
    Report Date
    April 9, 2020
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K141971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF A PATIENT INJURY THAT OCCURRED ON (B)(6) 2020. THE OPERATOR OF THE DEVICE PLACED THE FOOT EXTENDER DEVICE ACCESSORY ON THE DEVICE PATIENT BED (PHS - PATIENT HANDLING SYSTEM). SUBSEQUENT USE OF THE ACCESSORY WAS CONTRARY TO USE INSTRUCTIONS. AS A RESULT, THE ACCESSORY AND PATIENT FELL FROM THE PHS. AS OF THE DATE OF THIS REPORT, THERE IS AN UNCONFIRMED HEAD INJURY SUSTAINED BY THE PATIENT. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441247 BIOGRAPH 64 AND BIOGRAPH 40 PET/CT KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10097302

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention