BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS HIGH FLOW HUMIDIFIER

    MDR report key: 3075031 · Received April 19, 2013

    Report

    Report Number
    2921601-2013-00003
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 18, 2013
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    PMA / PMN Number
    K113542
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, SALTER LABS CUSTOMER SERVICE RECEIVED A COMPLAINT REGARDING A BUBBLE HUMIDIFIER BOTTLE SPLITTING. REPORTEDLY, THE CUSTOMER HAD AN INCIDENT WHERE HUMIDIFIER BOTTLE SPLIT AND LOST PRESSURE AND HE "NEARLY PASSED OUT" AND HIS PULSE OXIMETER READ 78. THE CUSTOMER SAID THAT HE WAS USING A RESPIRONICS CONCENTRATOR WITH A SALTER LABS HUMIDIFIER BOTTLE WHEN THE INCIDENT TOOK PLACE AND THAT THE CONCENTRATOR WAS AWAY FROM ALL THE FURNITURE. THE ONLY THING TOUCHING THE HUMIDIFIER BOTTLE IS A STRAP WHICH HE DESCRIBED TO BE "FAIRLY TIGHT". THE PT WAS UNCLEAR HOW THE SPLIT ON THE HUMIDIFIER HAPPENED. A RESPIRATORY THERAPIST AT SALTER LABS SPOKE WITH THE CUSTOMER OVER THE PHONE ON (B)(4) 2013 AND ASKED HIM IF ANY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATED THAT HE DID NOT REQUIRE MEDICAL INTERVENTION OTHER THAN TO CONNECT HIS O2 LINE TO THE CONCENTRATOR OUTLET AND THEN TO REPLACE THE HUMIDIFIER WITH A NEW ONE. THE BOTTLES WERE RETURNED TO SALTER LABS FOR EVAL AND WERE VISUALLY INSPECTED. IT WAS CONFIRMED THAT THE BOTTLES HAVE CRACKED. HOWEVER, THE PRESSURE RELEASE VALVE ON THESE UNITS APPEAR TO BE WORKING PROPERLY (INDICATING THE SPLITTING IS NOT DUE TO PRESSURE ISSUES). THE MANNER IN WHICH THE UNITS WERE USED AND CLEANED IS BEING CLARIFIED WITH THE USER TO DETERMINE POTENTIAL ROOT CAUSES. THIS IS AN INTERIM REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170103 SALTER LABS HIGH FLOW HUMIDIFIER BUBBLE HUMIDIFIER BTT SALTER LABS 7900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other