BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITY DOCKING STATION

    MDR report key: 1909281 · Received November 17, 2010

    Report

    Report Number
    1220063-2010-00086
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER EVALUATED THE DEVICE AND FOUND THAT THE IMPACT FROM THE REPORTED COLLISION WAS THE ROOT CAUSE OF THIS EVENT. THIS IS OUTSIDE OF THE SCOPE OF NORMAL USE AND THEREFORE IS NOT A PRODUCT MALFUNCTION. THE LIMITED SPACE IN THE ROOM AND USER CONTRIBUTED TO AND CAUSED THE DEVICE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP HOUSING OF THIS DOCKING STATION SEPARATED FROM THE BOTTOM HOUSING DURING A PROCEDURE. ACCORDING TO SERVICE REPORT, THE BIOMEDICAL ENGINEERING STAFF STATED THAT THE IDS WAS BUMPED INTO RATHER HARD WITHIN A CYSTOSCOPY ROOM. THE MONITOR DOCKED TO THE IDS REPORTEDLY FELL BUT WAS CAUGHT BY A STAFF MEMBER BEFORE COMING INTO CONTACT WITH THE FLOOR. THERE WERE NO INJURIES REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DOCKING STATION PATIENT MONITOR DOCKING STATION MHX DRAEGER MEDICAL SYSTEMS, INC. 5206110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO