BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING IV POLE

    MDR report key: 11957658 · Received June 8, 2021

    Report

    Report Number
    3005860720-2021-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 8, 2021
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG
    Product Code
    FOX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1181-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. REPORT SOURCE OTHER: (B)(4). THE REPORTED EVENT WAS DUE TO EXCESSIVE TAP DRILL DEPTH RESULTING IN THE THIN WALL SECTION OF THE BLOCK BRACKET ASSEMBLY WHICH IS THE BRACKET THAT ATTACHES THE POLE TO THE BED. A FALL OF THE ROTATING IV POLE COULD RESULT IN AN INJURY TO A BYSTANDER HOLDING THE PATIENT OR TO THE OPERATOR. GE HEALTHCARE INITIATED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 12/08/2017. NO REPORT OF PATIENT INVOLVEMENT. REPORT SOURCE OTHER: (B)(4). THE REPORTED EVENT WAS DUE TO EXCESSIVE TAP DRILL DEPTH RESULTING IN THE THIN WALL SECTION OF THE BLOCK BRACKET ASSEMBLY WHICH IS THE BRACKET THAT ATTACHES THE POLE TO THE BED. A FALL OF THE ROTATING IV POLE COULD RESULT IN AN INJURY TO A BYSTANDER HOLDING THE PATIENT OR TO THE OPERATOR. GE HEALTHCARE INITIATED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 12/08/2017.

    Description of Event or Problem · 1

    PER MEDWATCH (B)(4): "NURSE REPORTED SHE WAS PUTTING AN OXYGEN FLOW MONITOR ON THE WALL BEHIND AN INFANT WARMER IN THE WELL-BABY NURSERY. SHE MOVED THE OHMED 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 THE 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. NO PATIENT WAS PRESENT DURING THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859977 ROTATING IV POLE STAND, INFUSION FOX GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG 6600-0851-800

    Patients

    Seq Age Sex Outcome Treatment
    1