BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23408507 · Received October 28, 2025

    Report

    Report Number
    3016541541-2025-00078
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS REQUESTED CLARITY ON WHEN THE CLIENT STARTED ELOPING THE BED AND IF THE CLIENT HAS OTHER SAFETY SHEETS THAT ARE FUNCTIONING CORRECTLY BUT THE DME REPRESENTATIVE DID NOT HAVE THAT INFORMATION. SENSORY MEDICAL REQUESTED TO HAVE THE FAMILY CONTACT THE COMPANY DIRECTLY. SENSORY MEDICAL HAS SENT REPLACEMENT SHEETS TO THE DME FOR THE FAMILY. 230926M16 IS THE LOT FOR THE SAFETY SHEET. REVIEW OF MANUFACTURING RECORDS CONFIRM ALL IN PROCESS AND FINAL INSPECTIONS PASSED. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ENTRAPMENT AND OTHER SAFETY CONCERNS. PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "USE THE MAINTENANCE CHECKLIST IN THE MANUAL TO INSPECT THE CANOPY, SEAMS, ZIPPERS, ELECTRONIC ACCESSORIES, CORDS, METAL FRAME, SCREWS, SLATS, LOCKS, AND SAFETY SHEETS EVERY 30 DAYS." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "IF ANY DAMAGE IS PRESENT, IMMEDIATELY DISCONTINUE USE AND CONTACT CUBBY FOR REPAIR OR REPLACEMENT." ON PAGE 15 "WHAT HAPPENS IF MY CUBBY RIPS OR I NOTICE OTHER DAMAGE? PLEASE CONTACT US RIGHT AWAY. ONLY USE YOUR CUBBY BED WHEN IT IS ASSEMBLED CORRECTLY AND IS IN SAFE WORKING CONDITION." ON PAGE 22 "DISCONTINUE USE AND CONTACT US IMMEDIATELY IF ANYTHING IS DAMAGED OR MISSING." ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "SAFETY SHEET FABRIC, CORD LOOP AND ZIPPERS HAVE NO TEARS, RIPS OR SNAGS AND LOCK IS SECURED." ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "EACH ZIPPER ON THE CANOPY IS FUNCTIONAL AND SEAMS OF ZIPPERS ARE INTACT" ADDITIONAL INVESTIGATION IS NEEDED, AND SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    THE COMPLAINANT IS A DURABLE MEDICAL EQUIPMENT (DME) REPRESENTATIVE. PER THE DME REPRESENTATIVE, THE SAFETY SHEET ZIPPER HAS BROKEN AND THE CHILD HAS BEEN ELOPING FROM THE BED. THE COMPLAINANT STATED THE CHILD WAS NOT INJURED AND THAT LOCKS WERE IN USE BY THE FAMILY. A PICTURE SHOWS A LONG TEAR ALONG THE SEAM OF THE ZIPPER. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744942 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 230926M16 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown