BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23213992 · Received October 3, 2025

    Report

    Report Number
    3016541541-2025-00070
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS ASKED THE COMPLAINANT TO FOLLOW UP WITH THE FAMILY ON USE OF LOCKS, WHEN THE FAMILY NOTICED THE DAMAGE IN RELATION TO THE EVENT, TO PROVIDE FURTHER INFORMATION ON THE DAMAGE THAT OCCURRED TO THE SHEET, AND TO REQUEST A RETURN OF THE DAMAGED SHEET. 231025M01 IS THE LOT FOR THE SAFETY SHEET. REVIEW OF MANUFACTURING RECORDS CONFIRMED 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 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 COMPLAINANT IS A DME COMPANY REPRESENTATIVE ON BEHALF OF A CLIENT. PER COMPLAINANT, THE CHILD BROKE THE SAFETY SHEET ZIPPER AND ESCAPED THE BED. THE COMPLAINANT DID NOT PROVIDE PICTURES OR KNOW WHETHER THE LOCKS WERE IN USE AT THE TIME OF THE ESCAPE. THE COMPLAINANT CONFIRMED THE CHILD WAS NOT INJURED AND STATED THE FAMILY HAD NO OTHER SAFETY SHEETS. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904272 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 231025M01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown