BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 7402570 · Received April 6, 2018

    Report

    Report Number
    1825014-2018-00004
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 6, 2018
    Manufacturer
    IHB OPERATIONS B.V.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MODEL #: 3AFC-M (SN:(B)(4)) FROM BOOM F FELL DURING A CASE AT (B)(6) MEDICAL CENTER. SKYTRON DISTRIBUTOR, (B)(4) CONFIRMED THE SERIAL NUMBER FROM THE HUB OF THE BOOM THAT THE 3AFC-M FELL FROM. SERIAL NUMBER (B)(4) IS THE SERIAL ATTACHED TO A LIGHT WEIGHT HUB THAT WAS USED FOR BOOM F ON SHOP ORDER (B)(4) AND ON CUSTOMER ORDER (B)(4) FOR (B)(6) MEDICAL CENTER. DURING OUR INVESTIGATION WE HAVE PHOTO DOCUMENTATION THAT THE 3AFC-M (SN: (B)(4)) WAS NOT INSTALLED AT SKYTRON AND WAS INSTALLED IN THE FIELD DURING INSTALLATION. WE WERE NOT ABLE TO LOCATE THE INSTALLATION RECORDS ON SERVICE BRIDGE AT THIS TIME FROM THE (B)(4). FROM THE PHOTOS AND THE INFORMATION THAT WE WERE PROVIDED FROM THE (B)(4), IT WAS DETERMINED THAT THE BRASS BRAKE KEY ((B)(4)) WAS NOT INSTALLED AND IS A PRIMARY SUPPORT FOR HOLDING THE 3T2 ARM AND THE 3AFC ARM TOGETHER. THE BALL STOP BOSS ((B)(4)) WAS INSTALLED BUT THAT ALONE CANNOT SUPPORT THE 3AFC-M TO THE 3T2 SUFFICIENTLY. THE ONLY FORCE THAT WAS HOLDING THE 3AFC-M TO THE 3T2 WAS THE CANTILEVER WEIGHT. IT WAS LATER DETERMINED THAT THE 3AFC-M HAS COSMETIC DAMAGE AND COULD BE ATTACHED TO BOOM F AFTER A NEW HARDWARE SET CONTAINING NEW COVERS AND MOUNTING EQUIPMENT REPLACED ANY DAMAGED COVERS DURING THE FALL. THE APPLICABLE REPLACEMENT PARTS WERE ORDERED BY THE (B)(4). PO: (B)(4) WAS SENT IN FROM THE (B)(4) FOR 2X REPLACEMENT HARDWARE KITS. ONE BEING THE HARDWARE KIT FOR A 3AFC ((B)(4)) AND THE OTHER BEING THE HARDWARE KIT FOR 3T2 ((B)(4)). BOTH OF THESE KITS WERE GIVEN TO (B)(4) WHILE HE WAS SKYTRON. HE WILL BE BRINGING THESE KITS BACK WITH HIM ON HIS WAY BACK TO (B)(4) ON 03/28/2018 TO REINSTALL 3AFC-M (SN: (B)(4)) TO BOOM F AT (B)(6) MEDICAL CENTER. SKYTRON COMPLAINT NUMBER (B)(4). THERE WERE NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244600 SKYTRON 3AFC-M SPRING ARM FQO IHB OPERATIONS B.V. 3AFC-M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other