BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    MDR report key: 1135689 · Received August 22, 2008

    Report

    Report Number
    3023361-2008-00045
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    August 22, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS REPORT IS BEING SUBMITTED AS A RESULT OF A REEVALUATION OF PAST COMPLAINTS BY SPACELABS. ALTHOUGH A REPORT HAD NOT PREVIOUSLY BEEN FILED FOR THIS INCIDENT, WE HAVE CONCLUDED THAT A REPORT IS APPROPRIATE. WE ARE NOW REPORTING THIS INCIDENT IN ACCORDANCE WITH 21 CFR 803. SPACELABS HAS PREVIOUSLY REPORTED THIS TEMPERATURE ADAPTER CABLE ASSEMBLY ISSUE TO THE FDA PER 21 CFR 806 AS PART OF A CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT EIGHT TEMPERATURE ADAPTER CABLE ASSEMBLIES, PART NUMBER 700-0031-00, WERE CAUSING INTERMITTENT DROPOUTS OR NOT SIGNING ON. THE CUSTOMER REPORTED THAT IN THIS FAILURE MODE, THE TEMPERATURE VALUE COULD NOT BE VIEWED ON THE MONITOR. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE ADAPTER CABLE ASSEMBLY NONE DRG SPACELABS HEALTHCARE OSC 06/07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other