BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE E.CAM DUAL CAMERA

    MDR report key: 8729304 · Received June 24, 2019

    Report

    Report Number
    1423253-2019-00004
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K142006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF AN OPERATOR INJURY ON (B)(6) 2019. THE OPERATOR HAS REPORTED DIFFICULTY MOVING THE PATIENT HANDLING SYSTEM - BED (PHS) OF THE E.CAM GAMMA CAMERA SYSTEM. A CUSTOMER SITE VISIT CONCLUDED THAT THERE WAS A MAINTENANCE ISSUE (GREASE BUILD UP ON THE RAILS) AND A BED ALIGNMENT ISSUE. INCREASED RESISTANCE WAS OBSERVED PRIOR TO CORRECTING THE ISSUES. THE OPERATOR REPORTS THAT BY USING THE SYSTEM WITH INCREASED RESISTANCE OVER AN EXTENDED PERIOD HAS RESULTED IN NECK PAIN AND SHOULDER PAIN/'BURNING SENSATION" FOR WHICH SHE HAS BEEN PRESCRIBED PHYSICAL THERAPY. A SPECIFIC EVENT DATE IS NOT AVAILABLE AS THE OPERATOR DESCRIBED THAT THE PROBLEM WAS CUMULATIVE OVER A PERIOD OF A YEAR. A SPECIFIC DIAGNOSIS IS NOT AVAILABLE, DESPITE NUMEROUS ATTEMPTS TO OBTAIN THAT INFORMATION. IT IS ALSO NOT KNOWN IF THIS OPERATOR HAD ANY PRE-EXISTING CONDITIONS THAT CONTRIBUTED TO THE PAIN AND SENSATION DESCRIBED. THERE ARE NO OTHER CONFIRMED, DOCUMENTED INJURIES TO ANY OTHER PERSON AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520573 SIGNATURE E.CAM DUAL CAMERA GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 7823946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention