BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 17 M PATIENT MONITOR

    MDR report key: 6100895 · Received November 14, 2016

    Report

    Report Number
    3007222337-2016-00033
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 22, 2016
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MHX
    PMA / PMN Number
    K143195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE DEFECTIVE HOSES WERE RETURNED FOR EVALUATION. IT WAS DETERMINED THAT THE LEAK WAS CAUSED BY THE DETERIORATION OF THE INNER O-RING OF THE NIBP HOSE, DUE TO THE USE OF NON-RECOMMENDED CLEANING AGENT BY THE CUSTOMER. THE CUSTOMER WAS PROVIDED A LIST OF RECOMMENDED CLEANING AGENTS, ALSO LOCATED IN THE OPERATOR'S MANUAL. MINDRAY DS, USA, INC. ((B)(4)). (EXEMPTION # E2015032).

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION # E2015032).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON INVASIVE BLOOD PRESSURE HOSE USED WITH THE PASSPORT 12M PATIENT MONITOR WAS LEAKING AND THE MONITOR PRESENTED AN ERRONEOUS VALUE. THE HOSPITAL STAFF TREATED THE PATIENT UNDER THE IMPRESSION THAT THESE WERE ACCURATE READINGS AND ADMINISTERED MEDICATION. IT WAS ONLY AFTER THE PATIENT DID NOT RESPOND TO THE MEDICATION THAT THE BLOOD PRESSURE READINGS WERE FOUND TO BE REPORTING LOWER THAN ACTUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON INVASIVE BLOOD PRESSURE HOSE USED WITH THE PASSPORT 12M PATIENT MONITOR WAS LEAKING AND THE MONITOR PRESENTED AN ERRONEOUS VALUE. THE HOSPITAL STAFF TREATED THE PATIENT UNDER THE IMPRESSION THAT THESE WERE ACCURATE READINGS AND ADMINISTERED MEDICATION. IT WAS ONLY AFTER THE PATIENT DID NOT RESPOND TO THE MEDICATION THAT THE BLOOD PRESSURE READINGS WERE FOUND TO BE REPORTING LOWER THAN ACTUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751603 PASSPORT 17 M PATIENT MONITOR PATIENT MONITOR MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 6803F-PA00002

    Patients

    Seq Age Sex Outcome Treatment
    1