BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI CRADLE

    MDR report key: 6198582 · Received December 22, 2016

    Report

    Report Number
    3010293992-2016-00300
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 11, 2016
    Report Date
    April 24, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE PROBLEM WAS REPORTED BY A CUSTOMER FROM (B)(6): MINI CRADLE FAILURE LEADS TO DELAY IN PUMP USE.

    Description of Event or Problem · 0

    THE PROBLEM WAS REPORTED BY A CUSTOMER FROM (B)(6): MINI CRADLE FAILURE LEADS TO DELAY IN PUMP USE. PUMP TREATMENT INFORMATION:NA. TYPE OF DRUG:NA. HUMAN HARM: NO. DELAY IN THERAPY: YES. MEDICAL INTERVENTION NEEDED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849952 MINI CRADLE MINI CRADLE MRZ Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1