BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTICARE PLATINUM

    MDR report key: 1828919 · Received September 3, 2010

    Report

    Report Number
    1220984-2010-00005
    Event Type
    Other
    Date Received
    September 3, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    PMA / PMN Number
    K030666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, AN HOLOGIC FIELD ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM. THE FIELD ENGINEER CHECKED FOR LOOSE GROUNDING AND FLOATING VOLTAGE ON THE SYSTEM FRAME AND TABLE TOP. ALL READINGS WERE WELL BELOW SPECIFICATION AND WAS CONFIRMED BY THE SITE BIOMEDICAL GROUP. THE MULTICARE SYSTEM IS RUNNING FINE WITH NO PROBLEMS REPORTED. HOLOGIC INC. HAS CONCLUDED THIS INCIDENT IS NOT DUE TO A MALFUNCTION OF THE MULTICARE PLATINUM SYSTEM.

    Description of Event or Problem · 1

    THE USER FACILITY CALLED TO SAY THAT THE PREVIOUS WEEK A PATIENT REPORTED WHAT SHE DESCRIBED AS A SHOCK WHILE LAYING PRONE ON A MULTICARE PLATINUM SYSTEM. AT FIRST IT WAS REPORTED THIS OCCURRED DURING AND EXPOSURE, BUT A FOLLOW-UP CONVERSATION REVEALED THAT IT OCCURRED PRIOR TO AN EXPOSURE. THE PATIENT REPORTED A SUDDEN PAIN IN THE AREA OF HER RIBS AND BREASTS. THE TECHNOLOGIST STATED THE SUDDEN PAIN MAY HAVE BEEN DUE TO THE PATIENT PINCHING A NERVE WHILE SHE WAS IN THE PRONE POSITION. THE PATIENT WAS EVALUATED BY A PHYSICIAN (RADIOLOGIST) AT THE SITE AND NO INJURY WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other