BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 8624090 · Received May 20, 2019

    Report

    Report Number
    3004972304-2019-00030
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 11, 2019
    Report Date
    August 8, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION. THE ALLEGED INCIDENT REPORTED COULD BE DUPLICATED AS THERE WAS A LARGE LEAK AT THE BACK OF THE SF QDV AS THE FITTING WAS LOOSE AND HAD NOT BEEN TIGHTENED CORRECTLY. REGULAR LEAK TESTING IS RECOMMENDED AS PART OF PREVENTATIVE MAINTENANCE AS PER THE PRODUCT TECHNICAL SERVICE MANUAL. THIS LEAK SHOULD HAVE BEEN IDENTIFIED DURING FILLING OF THE UNIT AS IT IS LARGE. THE QDV WOULD NOT HAVE COME LOOSE AFTER DELIVERY AND FILLING UNDER NORMAL USE.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NO DETAIL INFORMATION REGARDING THE INCIDENT IS AVAILABLE RIGHT NOW. ACCORDING TO THE COMPLAINT DESCRIPTION THE CONTENT FROM THE HOME LOX VESSEL 30 L LEAKED ALL OVER THE FLOOR. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416494 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13256988

    Patients

    Seq Age Sex Outcome Treatment
    1