BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING IV POLE

    MDR report key: 7099469 · Received December 8, 2017

    Report

    Report Number
    1121732-2017-00002
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 16, 2017
    Report Date
    December 8, 2017
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FOX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FMI 32059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WILL INITIATE AND REPORT A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806. THE GEHC INTERNAL FIELD MODIFICATION NUMBER IS (B)(4). PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 12/1/2017 EMAIL AND PHONE CALL, 12/4/2017 PHONE CALL, 12/5/2017 EMAIL AND PHONE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ROTATING IV POLE BROKE AWAY FROM THE BED STATION WHILE IN USE WITH A PATIENT. THE NURSE WAS ABLE TO CATCH THE POLE BEFORE IT FELL OVER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880155 ROTATING IV POLE STAND, INFUSION FOX OHMEDA MEDICAL 2082844-001

    Patients

    Seq Age Sex Outcome Treatment
    1