BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2434114 · Received January 30, 2012

    Report

    Report Number
    9710055-2012-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 1, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH EVALUATED THE DEVICE. HE FOUND THAT THE DAMAGE OCCURRED AT THE LOCATION WHERE THE CUPOLA COUPLES WITH THE SPRING ARM. HE REPLACED THE DAMAGED SPRING ARM, AS WELL AS TWO SIMILAR UNITS IN THE FACILITY. THE POWERLED YEARLY PREVENTIVE MAINTENANCE PROGRAM REQUESTS A VERIFICATION OF THE PROPER BALANCING OF SPRING ARM, AS WELL AS A REPLACEMENT EVERY 6 YEARS AS SPRING ARMS WEAR OUT IN TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A POWERLED 700 CUPOLA BECAME SEPARATED FROM THE SPRING ARM WHILE THE OPERATING ROOM STAFF WAS MOVING IT INTO POSITION FOR A CASE. THE CUPOLA REMAINED SUSPENDED BY THE WIRING FROM THE SPRING ARM. THE HOSP DID NOT REPORT INJURIES. FACTORY REF#: (B)(4). IMPORTER REF#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FSY MAQUET SAS PWD 700 DF

    Patients

    Seq Age Sex Outcome Treatment
    1