BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARD

    MDR report key: 20629611 · Received November 7, 2024

    Report

    Report Number
    20629611
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 30, 2024
    Manufacturer
    HARD MFG. CO., INC.
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MANY HARD CRIB MATTRESSES WERE FOUND TO HAVE LARGE, HARD LUMPS IN THEM. ISSUE WAS FOUND ON CRIBS IN STORAGE. BIOMED CUT OPEN A MATTRESS AND FOUND THAT THE INNER BLUE FIRE RESISTANT LAYER WAS DETACHING FROM THE MATTRESS AND BUNCHING UP TOWARDS FOOT OF CRIB. ISSUE FOUND ON ~50% OF THE HARD CRIBS (~35 TOTAL CRIBS HAD THIS SAME MATTRESS ISSUE). WE ARE CONCERNED THIS COULD CREATE A PATIENT SAFETY ISSUE IF PATIENT CANNOT STAY POSITIONED AS INTENDED DUE TO THE LUMP IN MATTRESS. MATTRESSES WERE MANUFACTURED IN LATE [DATE REDACTED], THEY ARE [AGE REDACTED]. CRIBS WERE PURCHASED AND INSTALLED AT SITE IN [DATE REDACTED]. BIOMED REPLACED MATTRESSES ON CRIBS THAT HAD THIS ISSUE; ESCALATED TO HARD MFG BUT DID NOT RECEIVE A RESPONSE. MANUFACTURER RESPONSE FOR CRIB, (BRAND NOT PROVIDED) (PER SITE REPORTER). REPORTED ISSUE TO MANUFACTURER ON DAY IT WAS FOUND, HAVE NOT YET RECEIVED A RESPONSE DESPITE SEVERAL FOLLOW UP EMAILS. BIOMED HAS ORDERED AND RECEIVED REPLACEMENT MATTRESSES IN THE INTERIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46756 HARD BED, PEDIATRIC OPEN HOSPITAL FMS HARD MFG. CO., INC. PC1843-CGP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose