BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-UP ACCESSORY KIT

    MDR report key: 2073249 · Received April 25, 2011

    Report

    Report Number
    2073249
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PHILIPS RESPIRONICS HEALTHDYNE
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE PROCESS REVIEW, IT WAS DISCOVERED THAT APNEA MONITOR SENSOR WITH BELTS DID NOT CARRY A MANUFACTER'S LABEL ON PACKAGE. WHILE NURSES KNEW AND RECOGNIZED THE PRODUCT, ABSENCE OF MANUFACTURER'S LABEL INTRODUCES POTENTIAL FOR CONFUSION.THIS PRODUCT AS IT IS DISTRIBUTED DOES CARRY A HOSPITAL-PRODUCED LABEL WITH ITEM NUMBER, BAR CODE AND SHORT DESCRIPTION. HOWEVER, THIS IS A DISTRIBUTION LABEL. ======================MANUFACTURER RESPONSE FOR APNEA MONITOR ACCESSORY KIT, START-UP ACCESSORY KIT======================VENDOR ASSURED US OF CALL BACK; HAVE YET TO HEAR BACK FROM MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 START-UP ACCESSORY KIT APNEA MONITOR ACCESSORY KIT FLS PHILIPS RESPIRONICS HEALTHDYNE 9916-12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *