BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS HUMIDIFIER BUBBLE HUMIDIFIER

    MDR report key: 2602558 · Received May 11, 2012

    Report

    Report Number
    2921601-2012-00006
    Event Type
    Other
    Date Received
    May 11, 2012
    Report Date
    May 11, 2012
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OXYGEN CYLINDER COMPANY REP DID MENTION THAT THE UNIT WAS TESTED AT THEIR COMPANY USING TAP WATER. IT IS IMPORTANT TO NOTE THAT THE AMOUNT OF CALCIFICATION ON THE UNIT SUGGESTS THAT TAP WATER WAS USED AND THAT SOME TIME HAD PASSED BEFORE SALTER RECEIVED THE UNIT. ALSO, THE LOCATIONS OF THE CALCIFICATION SUGGEST THAT THE ANALYSIS PERFORMED AT THE OXYGEN CYLINDER COMPANY MAY HAVE COMPROMISED THE UNIT. OVERALL, THE ANALYSIS INCLUDED THAT THE CAUSE OF THE LEAK WAS A CRACK IN THE WING-NUT PORTION OF THE HUMIDIFIER AND THE MOST LIKELY ROOT CAUSE OF THE CRACKING WAS IMPROPER SET UP, WHERE TORQUE WAS APPLIED TO THE UNIT STRESSING THE CONNECTING PORTION. IT IS IMPORTANT TO NOTE THAT THE PT DID NOT SEEK MEDICAL ATTENTION AND IS REPORTEDLY DOING FINE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    ON 04/20/2012, SALTER LABS RECEIVED COMMUNICATION FROM CUSTOMER (B)(6) WITH AN INITIAL REPORT SUBMITTED TO THE (B)(6) REGARDING AN INCIDENT WHICH TOOK PLACE IN (B)(6) INVOLVING A HUMIDIFIER DEVICE. REPORTEDLY, THERE WAS A LEAK BETWEEN THE "CLAMPING MECHANISM" OF THE HUMIDIFIER, WHICH CAUSED OXYGEN SUPPLY TO BE 11 PM RATHER THAN 31 PM. ALSO INVOLVED IN THE INCIDENT WAS AN OXYGEN CYLINDER (PRODUCED BY ANOTHER MFR). THE HUMIDIFIER WAS RETURNED TO SALTER LABS FOR ANALYSIS. THE HUMIDIFIER APPEARED TO BE HEAVILY USED AND HAD INDICATIONS OF MINERAL DEPOSITS. UPON ANALYSIS, A CRACK WAS CONFIRMED INSIDE THE WING-NUT CONNECTING PORTION OF THE HUMIDIFIER. THE LEAK WAS ALSO CONFIRMED TO CAUSE A DRIP FROM 31 PM TO 11 PM. AFTER TWO ATTEMPTS AT CONTACT WITH THE INITIAL REPORTER OF THE INCIDENT TO THE (B)(6) ( A REP FROM THE OXYGEN CYLINDER INVOLVED IN THE INCIDENT), SALTER WAS TOLD THAT THE PT WAS A FEMALE AND THAT SHE DID NOT NEED TO SEEK MEDICAL ATTENTION AS A RESULT OF THIS INCIDENT, THAT THE INCIDENT OCCURRED THE FIRST DAY THE UNIT WAS IN USE AND THAT THE PT HAD USED DI WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS HUMIDIFIER BUBBLE HUMIDIFIER HUMIDIFIER WITH 6PSI POP OFF BTT SALTER LABS 7600 101011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other