BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23549546 · Received November 13, 2025

    Report

    Report Number
    3016541541-2025-00083
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION TO AID IN THE INVESTIGATION ON THE FOLLOWING DATES: 10/17/2025, 10/20/2025, 10/23/2025, 10/27/2025, 10/29/2025, AND 11/04/2025. THE COMPLAINANT DID NOT PROVIDE ANY OF THE REQUESTED INFORMATION AND THE DAMAGED SHEET WAS NOT RETURNED FOR EXAMINATION BY SENSORY MEDICAL. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE LOT NUMBER FOR THE SAFETY SHEET IS 240715M22. THE MANUFACTURING RECORDS WERE REVIEWED. THERE WERE ZERO NONCONFORMITIES DOCUMENTED IN THE RECORDS. ALL INSPECTED UNITS PASSED THE ACCEPTANCE CRITERIA. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ELOPEMENT AND OTHER SAFETY CONCERNS. PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR ENTRAPMENT HAZARD. "OPENINGS IN AND BETWEEN BED PARTS CAN ENTRAP THE HEAD AND THE NECK." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR ENTRAPMENT HAZARD. "TO AVOID DANGEROUS GAPS DO NOT USE THIS PRODUCT WITHOUT THE SAFETY SHEETS COMPLETELY ZIPPED AND LOCKED IN PLACE TO THE SIDEWALL. SAFETY SHEET WITH LOCK IN PLACE IS ALWAYS REQUIRED." 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." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS AND SAFETY SHEETS. PAGE 11 INSTRUCTS TO SECURE THE SAFETY SHEET ZIPPER TO THE LOOP ON THE CANOPY WITH THE LOCK TO PREVENT THE PATIENT USER FROM REMOVING THE SHEET. DO NOT USE THE PRODUCT WITHOUT THE SAFETY SHEETS ZIPPED AND LOCKED IN PLACE. PAGE 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. 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." PAGE 22 OF THE USER MANUAL, MAINTENANCE CHECKLIST, DESCRIBES TO DISCONTINUE USE OF THE BED IF ANYTHING IS DAMAGED OR MISSING. 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 DME REPRESENTATIVE REPORTED THAT THEIR CLIENT EXPERIENCED A DAMAGED SAFETY SHEET ZIPPER. PER THE DME REPRESENTATIVE, THE SAFETY SHEET ZIPPER BROKE AND NEEDS TO BE REPLACED. PER THE COMPLAINANT, THE PATIENT IS NOT INJURED BUT DOES GET STUCK WHEN TRYING TO GET OUT. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882479 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 240715M22 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown