BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE STROLLER

    MDR report key: 3449594 · Received October 25, 2013

    Report

    Report Number
    3004822415-2013-00017
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    September 19, 2013
    Report Date
    October 18, 2013
    Manufacturer
    CAIRE INC
    Product Code
    BYJ
    PMA / PMN Number
    K800742A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PORTABLE LIQUID OXYGEN DEVICE, CAIRE STROLLER (SN (B)(4)), WAS RETURNED TO CAIRE FOR FURTHER INVESTIGATION AND TESTING. EXTERNAL INSPECTION WITH THE SHROUD STILL ON THE PORTABLE REVEALED THE SEAL WITHIN THE QDV ON THE STROLLER WAS BROKEN, POTENTIALLY ALLOWING LOX TO LEAK DURING THE FILLING PROCESS. THE EXTERNAL INSPECTION ALSO FOUND THE WARNING LABEL P/N 13657677 TO BE MISSING. AFTER THE SHROUD WAS TAKEN OFF, IT WAS OBSERVED THAT THE RIGHT MOUNT TAB FOR THE METER WAS FRACTURED. UPON PRESSURIZING THE ENTIRE UNIT, A WATER BATH WAS USED TO CHECK FOR ANY BUBBLES THAT WOULD REVEAL LEAKS ON THE UNIT. THE UNIT WAS SUBMERGED IN AN UPRIGHT POSITION SO THAT NONE OF THE ELECTRONICS WERE SUBMERGED IN WATER. NO LEAKS WERE OBSERVED. THE RESULTS INDICATE THAT WHEN THE PT MANUAL GUIDELINES ARE FOLLOWED, THERE IS NO INDICATION OF LOX LEAKAGE FROM THE OUTLET BARB AND THUS NO INDICATION THAT ANY WOULD REACH THE CANNULA. ALTHOUGH THE COMPLAINT COULD NOT BE DUPLICATED, IT WAS STILL BEST TO CONTINUE THE INVESTIGATION FOR ANY SIGN OF HOW LOX MIGHT HAVE LEAKED FROM THE CANNULA. THE REST OF THE TESTING, HOWEVER, SHOWED NO SIGNIFICANT SYMPTOMS THAT MIGHT HAVE LED TO THE LOX LEAK. ALL THE FLOW SETTINGS WERE WITHIN SPECIFICATION; RUNNING HEAD PRESSURE WAS NORMAL. NER WAS SLIGHTLY OUT OF SPECIFICATIONS AND FURTHER INVESTIGATION AS TO THE VACUUM LEVEL WOULD BE REQUIRED. NONE OF THE PERFORMED TESTS GAVE ANY REASON TO BELIEVE THAT PROPER USE WOULD WARRANT LOX LEAKING FROM THE OUTLET BARB.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT BY (B)(4) ON (B)(6) 2013. "PORTABLE STROLLER LEAKING/SHOOTING LTQ INTO PT'S CANNULA." NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549417 CAIRE STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC 10564109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other