BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STROLLER

    MDR report key: 8323257 · Received February 8, 2019

    Report

    Report Number
    3004972304-2019-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    December 1, 2018
    Report Date
    April 3, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT WAS RETURNED FOR AN EVALUATION. THE DEVICE IN QUESTION COULD NOT BE LIQUID TESTED DUE A DAMAGED QDV RETAINING RING CAUSING LOX TO VENT AFTER FILLING AND THEREFORE ALLEGED INCIDENT COULD BE DUPLICATED. LIQUID TESTING IS DETAILED AS PART OF MANUFACTURERS RECOMMENDED MAINTENANCE, THE DAMAGE TO THE QDV RETAINING RING IS VERY RARELY SEEN AND IS MOST LIKELY CAUSED BY ATTEMPTING TO FORCE APART STUCK QDV'S AFTER FILLING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED ESCAPE OF LIQUID OXYGEN FROM ONE OR BOTH UNITS. CLIENT WAS UNABLE TO REACH THEIR SUPPLIER (OUR CUSTOMER) ON THE EMERGENCY PHONE LINE, SO CALLED THE FIRE SERVICE. AMBULANCE AND POLICE WERE ALSO CALLED TO THE SCENE. THE FIRE SERVICE EVACUATED THE BUILDING AND CONCLUDED THAT THERE WAS A FAULT WITH A UNIT. AFTER THEIR OWN INTERNAL INSPECTION OF THE UNITS, THE CUSTOMER SUSPECTS THAT THE PORTABLE UNIT SIMPLY ICED UP DURING FILLING DUE TO USER ERROR. UPDATE 15TH JANUARY 2019: INTERNAL REPORT FROM CUSTOMER (B)(6). LIBERATOR TANK WAS ICED UP AFTER FILLING UP THE STROLLER PORTABLE. PATIENT COULDN'T REACH THEIR SUPPLIER ON A SATURDAY SO CALLED THE EMERGENCY SERVICES INSTEAD. POLICE, FIRE AND AMBULANCE ALL ATTENDED THE SCENE. FIRE SERVICE EVACUATED THE BUILDING AND TOOK THE TANK OUTSIDE. THEY IDENTIFIED A FAULT WITH THE TANK BUT NO FURTHER DETAILS. A CHILD WAS TAKEN TO HOSPITAL. CLIENT CONTACTED THE CUSTOMER AFTER THE EVENT AND STATED THAT ALL IN THE BUILDING WERE IN DANGER OF THEIR LIVES. UPDATE 17TH JANUARY 2019: THE POLICE CONFIRMED THAT THEY TOOK NO OFFICIAL MEASURES IN RELATION TO THE INCIDENT AND THAT THEREFORE NO WRITTEN RECORD OF THE INCIDENT WAS MADE UPDATE 5TH FEBRUARY 2019: REPORT FROM FIRE SERVICE OF 2ND FEBRUARY. THE UNIT WAS IN THE LIVING ROOM, THE UNIT HAD ALREADY ICED UP SIGNIFICANTLY AT THE VALVE WHERE THE OXYGEN HAD ESCAPED. THE FIRE OFFICERS COULD NOT STOP THE ESCAPE OF GAS, SO THEY TOOK THE UNIT OUTSIDE TO LET THE REST OF THE GAS OUT IN A CONTROLLED MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116642 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 11933113

    Patients

    Seq Age Sex Outcome Treatment
    1