BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCOLD MOMCUBE BREAST MILK REFRIGERATOR

    MDR report key: 12985300 · Received December 10, 2021

    Report

    Report Number
    MW5105983
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 8, 2021
    Manufacturer
    SUMMIT APPLIANCE DIVISION, FELIX STORCH, INC.
    Product Code
    JRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN (B)(6) 2020 WE PURCHASED 14 MOMCUBE BREAST MILK REFRIGERATORS. THE REFRIGERATORS HAVE A LOCKING MECHANISM WHICH OFTEN FAILS TO LOCK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE MANUFACTURER TO FIX THE LOCKS WITHOUT ANY RESPONSE. WE ARE NOT ABLE TO ASSURE BREASTMILK IS SECURED AS REQUIRED BY REGULATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871870 ACCUCOLD MOMCUBE BREAST MILK REFRIGERATOR FREEZER JRM SUMMIT APPLIANCE DIVISION, FELIX STORCH, INC. ARS1MLMC-KAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other