BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPX 1

    MDR report key: 1060644 · Received June 10, 2008

    Report

    Report Number
    MW5007285
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 10, 2008
    Manufacturer
    RESPIRONICS
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE TRANSFORMER - IPX1 - ON THE BIPAP MODEL PRO 2 DOMESTIC, BECAME VERY HOT AND BEGAN TO BEEP AFTER ONLY 2 YEARS AND A FEW MONTHS AFTER PURCHASE. THE UNIT WAS TURNED OFF. AFTER HAVING GONE OVER NIGHT WITHOUT THE MACHINE AND OR OXYGEN THE PATIENT SUFFERED DAY TIME SLEEPINESS, FATIGUE, ELEVATED BLOOD PRESSURE AND A RACING HEART RATE. AN ATTEMPT TO USE THE PRODUCT AGAIN TO ALLEVIATE THE SYMPTOMS LISTED ABOVE, RESULTED IN THE UNIT MAKING A HIGH PITCHED HUM, BUT THE UNIT DID NOT COME ON, ONLY THAT THE TRANSFORMER CONTINUED TO BE HOT. THE MANUFACTURER-RESPIRONICS, SAYS THAT THE UNIT HAS BEEN DISCONTINUED. AFTER VIEWING THE FDA WEBSITE FOR RECALLS, THE ITEM WAS NOT LISTED. FREQUENCY: NIGHTLY. ROUTE: OTHER. DATES OF USE: INDEFINITE. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA. EVENT ABLATED AFTER USE STOPPED OR DOSE REDUCED: #1: NO; #2: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPX 1 BIPAP BZD RESPIRONICS MW 112RA2600N03
    2 BIPAP PRO 2 BIPAP BZD RESPIRONICS MW 112RA2600N03

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability