BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN US CORPORATION FOR CME AMERICA LLC BODYGUARD INFUCION PUMP PCA

    MDR report key: 10338028 · Received July 28, 2020

    Report

    Report Number
    MW5095764
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 24, 2020
    Manufacturer
    CODAN US CORP/ CAESAREA MEDICAL ELECTRONICS LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEAKING AT BLUE AREA WHERE PCA CONNECTS TO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800555 CODAN US CORPORATION FOR CME AMERICA LLC BODYGUARD INFUCION PUMP PCA SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORP/ CAESAREA MEDICAL ELECTRONICS LTD. 15844

    Patients

    Seq Age Sex Outcome Treatment
    1