BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCINNATI SUB-ZERO

    MDR report key: 7428526 · Received April 13, 2018

    Report

    Report Number
    7428526
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 19, 2018
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON NEEDED TO USE THE CSZ STAFF VEST #300 FOR COOLING PURPOSES AT THE START OF A CASE. WHEN THE COOLING UNIT WAS TURNED ON, THE VEST SPRAYED WATER OUT OF A DEFECTIVE SEAM WHILE ON THE SURGEON. THE SURGEON HAD TO CHANGE SCRUBS. THIS IS A ONE USE ONLY VEST AND WAS NEW OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273995 CINCINNATI SUB-ZERO PACK, HOT OR COLD, WATER CIRCULATING ILO CINCINNATI SUB-ZERO PRODUCTS, INC. 300 007240

    Patients

    Seq Age Sex Outcome Treatment
    1