BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2872020 · Received December 11, 2012

    Report

    Report Number
    1518293-2012-00230
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTS THAT DURING A UROLOGY PROCEDURE, THE TABLE MONITORS KEPT SHUTTING OFF. STAFF BROUGHT IN ANOTHER TOWER MONITOR AND THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED INJURY. THE NEXT DAY THE FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE FOR REPORT THAT ALL POWER WAS OFF TO THE ROOM AND FOUND INCOMING POWER LINE BREAKERS OFF. WHEN POWER TO ROOM WAS RESTORED, ALL EQUIPMENT WORKED NORMALLY WITH FSE CHECKING SYSTEM PER SERVICE CHECKLIST (B)(4). SYSTEM WAS RETURNED TO CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING A UROLOGY PROCEDURE, THE TABLE MONITORS KEPT SHUTTING OFF. STAFF BROUGHT IN ANOTHER TOWER MONITOR AND PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY. CUSTOMER DOES HAVE A BACKUP ROOM FOR PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK