BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING IV POLE

    MDR report key: 11731527 · Received April 27, 2021

    Report

    Report Number
    11731527
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 20, 2021
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED SHE WAS PUTTING AN OXYGEN FLOW MONITOR ON THE WALL BEHIND AN INFANT WARMER IN THE WELL-BABY NURSERY. SHE MOVED THE OHMEDA MEDICAL ROTATING IV POLE OUT OF THE WAY (WHICH IS ATTACHED TO THE INFANT WARMER) AND IT ALL SNAPPED OFF AND FELL. NURSE CHECKED THE SCREWS THAT SECURE THE ROTATING IV POLE TO THE WARMER AND THE METAL HOLDING IT TOGETHER HAD BROKEN. THE WEIGHT LIMIT FOR THE POLE IS 9 KG. THE TWO INFUSION DEVICES ON THE ROTATING IV POLE HAD A COMBINED WEIGHT OF 4.21 KG WHICH IS LESS THAN THE WEIGHT LIMIT. IF THERE HAD BEEN A BABY IN THAT WARMER IT COULD HAVE SEVERELY INJURED THE BABY. CLINICAL ENGINEERING COMPLETED AN INVESTIGATION OF THIS EVENT AND FOUND THAT THE INTERNAL SLEEVE IN WHICH THE BOLT THAT SECURES CLAMPING PART TO THE POLE WAS SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630135 ROTATING IV POLE STAND, INFUSION FOX OHMEDA MEDICAL LAU14256889

    Patients

    Seq Age Sex Outcome Treatment
    1