BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHILLER

    MDR report key: 781157 · Received November 2, 2006

    Report

    Report Number
    2129749-2006-00004
    Event Type
    Malfunction
    Date Received
    November 2, 2006
    Date of Event
    October 6, 2006
    Manufacturer
    SCHILLER AG
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FAILED SCHILLER PB1000 PATIENT DATA MODULE (PDM) UNIT WAS RETURNED TO EMAGEON FOLLOWING ITS REPLACEMENT AT THE CUSTOMER SITE. PER AGREEMENT WITH SCHILLER, EMAGEON TESTED THE RETURNED UNIT AND CONFIRMED THAT THE BLOOD PRESSURE CUFF DID NOT FULLY DEFLATE WITHIN THE SPECIFIED TIME PERIOD. THE FAILURE OF THE CUFF TO FULLY DEFLATE WAS BELIEVED BY EMAGEON TO BE CAUSED BY A PDM VALVE THAT WAS STUCK IN A SLIGHTLY OPEN POSITION. FOLLOWING OUR EVALUATION, EMAGEON RETURNED THE UNIT WITH FINDINGS TO SCHILLER AG. AT THE TIME OF THIS WRITING, THE DEVICE MANUFACTURER, SCHILLER AG, HAS YET TO COMPLETE THEIR EVALUATION OF THE UNIT. THE SCHILLER PB1000 PATIENT DATA MODULE IS A COMPONENT OF THE CAMTRONICS PHYSIOLOG PROGRAMMABLE DIAGNOSTIC COMPUTER SYSTEM (K013032). CAMTRONICS (ER#2129749) IS AN EMAGEON COMPANY (O/O #1220672). THIS REPORT IS SUBMITTED BY EMAGEON PER AGREEMENT WITH SCHILLER AG.

    Description of Event or Problem · 1

    AUTOMATIC BLOOD PRESSURE CUFF FAILED TO DEFLATE COMPLETELY, CAUSING THE PATIENT'S ARM TO TURN PURPLE. NO INJURY WAS REPORTED TO HAVE RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHILLER MONITOR, PHYSIOLOGICAL, PATIENT MHX SCHILLER AG PB1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other