BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MODEL 90207 ABP MONITOR

    MDR report key: 4815862 · Received June 3, 2015

    Report

    Report Number
    3010157426-2015-00115
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 6, 2015
    Report Date
    June 1, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    DXN
    PMA / PMN Number
    K103732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT DROPPED AN AMBULATORY BLOOD PRESSURE (ABP) MONITOR MODEL 90207-32 DURING AN OVERNIGHT OBSERVED STUDY, PICKED UP THE MONITOR AND PLACED IT UNDER HIS PILLOW TO CONTINUE DATA COLLECTION. LATER THE SAME NIGHT, THE UNIT BECAME VERY HOT AND EMITTED A BAD SMELL. THE PATIENT INFORMED THE NURSE. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359465 SPACELABS MODEL 90207 ABP MONITOR ABP MONITOR DXN SPACELABS HEALTHCARE LTD. 90207

    Patients

    Seq Age Sex Outcome Treatment
    1