BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO M-SERIES

    MDR report key: 2801239 · Received October 17, 2012

    Report

    Report Number
    2518422-2012-01924
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 21, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K063830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE COMPLAINT OF A THERMAL DAMAGE WAS CONFIRMED. THERE WERE SIGNS OF WATER INGRESS TO THE ELECTRONIC COMPONENTS INSIDE THE DEVICE LEADING TO A SHORT CIRCUIT AND SUBSEQUENT THERMAL DAMAGE TO THE ENCLOSURE. THE PRODUCT'S LABELING PROVIDES USER CARE AND HANDLING INSTRUCTIONS TO PREVENT WATER INGRESS FROM OCCURRING OR AFFECTING THE OPERATION OF THE DEVICE. THE MFR CONCLUDES THE PRODUCT FAILURE WAS CAUSED BY THE USER MISHANDLING/ABUSE. THE MFR CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) NOTIFIED THE MFR THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) HAD THERMAL DAMAGE AFTER HAVING FALLEN FROM A NIGHTSTAND. THERE WAS NO REPORT OF INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR AUTO M-SERIES CONTINUOUS POSITIVE AIRWAY PRESSURE BZD RESPIRONICS INC. 510M

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR M-SERIES (DC) HUMIDIFIER| (B)(4)