BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23490630 · Received November 6, 2025

    Report

    Report Number
    3016541541-2025-00079
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 5, 2025
    Report Date
    November 6, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL WAS MADE AWARE OF THE INITIAL COMPLAINT ON OCTOBER 5, 2025. SENSORY MEDICAL FIRST RECEIVED INFORMATION IN WHICH THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE ON OCTOBER 14, 2025. SENSORY MEDICAL ADVISED THE FAMILY TO DISCONTINUE USE OF THE BED UNTIL A RESOLUTION COULD BE REACHED. THE PARENT STATED SHE HAS DISCONTINUED USE OF THE BED. SENSORY MEDICAL FOLLOWED UP WITH THE PARENT ON (B)(6) 2025 REQUESTING CLARIFYING INFORMATION, AND DETAILS RELEVANT TO THE INVESTIGATION. SENSORY MEDICAL IS UNABLE TO CONFIRM IF THE ELOPEMENT OCCURRED DURING USE OF THE DAMAGED SAFETY SHEET ZIPPER, OR WHILE USING REGULAR NON-SAFETY SHEETS DUE TO LACK OF RESPONSES FROM THE PARENT. SENSORY MEDICAL HAS RECEIVED NO RESPONSE ON WHETHER LOCKS WERE IN USE ON THE SAFETY SHEET AT THE TIME OF THE EVENT. SENSORY MEDICAL REQUESTED RETURN OF THE DAMAGED SAFETY SHEET FOR EXAMINATION AND PROVIDED A RETURN SHIPPING LABEL. THE DAMAGED SHEET HAS NOT BEEN RETURNED AS OF THE WRITING OF THIS INVESTIGATION. 250514M14 IS THE LOT NUMBER FOR THE SAFETY SHEETS. REVIEW OF MANUFACTURING RECORDS CONFIRMS ALL INSPECTIONS WERE PERFORMED AND PASSED. 250704M04 IS THE LOT NUMBER FOR THE CANOPY. REVIEW OF MANUFACTURING RECORDS CONFIRMS ALL INSPECTIONS WERE PERFORMED AND 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. "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 SAFETY SHEETS AND LOCKS. 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. 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." PAGE 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. 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." PAGE 22 OF THE USER MANUAL, MAINTENANCE CHECKLIST, DESCRIBES DISCONTINUING 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 PARENT REPORTED THAT THE SAFETY SHEET ZIPPER BECAME DAMAGED DURING USE AND RESULTED IN A ZIPPER SEPARATION WHERE HER SON ELOPED FROM THE BED. THE PARENT PROVIDED TWO PHOTOS AND ONE VIDEO TO ASSIST SENSORY MEDICAL IN THE INVESTIGATION. ONE PHOTO SHOWS THE SAFETY SHEET ON THE BED WITH THE ZIPPER SEPARATED. ONE PHOTO SHOWS A SAFETY SHEET ZIPPER STUCK, AND APPEARS THE WASH LABEL IS STUCK IN THE SLIDER. THE ZIPPER TEETH ARE SEPARATED AT BOTH SIDES OF THE SLIDER. THE VIDEO SHOWS A SAFETY SHEET ON THE BED BUT NOT ZIPPED, AND SHOWS TWO ZIPPER SLIDERS ON THE CANOPY SIDE SAFETY SHEET ZIPPER, WHICH SUGGESTS THAT SAFETY SHEETS BROKE WITH THE SLIDER COMING OFF THE SAFETY SHEET AND STAYING ON THE CANOPY. THE PARENT STATED THAT SHE WAS USING REGULAR SHEETS AFTER THE SAFETY SHEETS HAD BECOME DAMAGED. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894556 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 250514M14 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male