BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS HIGH FLOW HUMIDIFIER

    MDR report key: 2721090 · Received August 27, 2012

    Report

    Report Number
    2921601-2012-00010
    Event Type
    Other
    Date Received
    August 27, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 27, 2012
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    PMA / PMN Number
    K113542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, SALTER LABS SALES REP WAS E-MAILED REGARDING AN INCIDENT ON (B)(6) 2012 WHERE A PATIENT'S OXYGEN SATURATION BEGAN DROPPING. A RESPIRATORY THERAPIST "NT SUCTIONED" THE PATIENT BUT HIS O2 SATURATION REMAINED AROUND 90. THE THERAPIST NOTED THAT THE HUMIDIFIER WAS BUBBLING BUT DID NOT OBSERVE AIR FLOWING THROUGH THE END OF THE BOTTLE TO THE PATIENT. THE HUMIDIFIER WAS REPLACED AND THE PATIENT'S SATURATION LEVELS RETURNED TO NORMAL. THE SALTER LABS SALES REP WENT TO THE HOSPITAL ON (B)(4) 2012 AND PERFORMED TESTING OF THE UNIT WITH THE POINT OF CARE NURSE, RUNNING THE HUMIDIFIER FROM 1-15 L/MIN. NO ISSUES WERE OBSERVED WITH THE PRODUCT INCLUDING NO VISIBLE DAMAGE (CRACKS) ON THE HUMIDIFIER. THE SALES REP AND THE POC NURSE CONCLUDED THAT THE "PRODUCT WAS EITHER CROSS THREADED BY THE CLINICIAN OR FLOW METER WAS MALFUNCTIONING." FURTHER, THE UNIT WAS RETURNED TO SALTER LABS FOR ANALYSIS. BECAUSE THE PATIENT WAS REPORTED TO HAVE AN INFECTIOUS DISEASE, TESTING WAS LIMITED TO VISUAL INSPECTION AND DETERMINING IF THE SLUG FREELY MOVED IN THE HUMIDIFIER. THE UNIT APPEARS TO BE FUNCTIONAL BASED ON THIS INSPECTION. THE MOST LIKELY ROOT CAUSE OF THE INCIDENT IS IMPROPER SET-UP (CROSS THREADING) OF THE UNIT. THIS IS A FINAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other