BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 22898300 · Received August 26, 2025

    Report

    Report Number
    3016541541-2025-00060
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 27, 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
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: THE DEVICE WAS RETURNED ON 08/13/2025 AND WAS INVESTIGATED ON 09/16/2025. UPON VISUAL INSPECTION, THE TEETH APPEARED CONFORMING ON THE FABRIC COVER, TECH HUB BLACK ZIPPER PIECE, AND ON CANOPY. EXCESSIVE FORCE WAS APPLIED TO THE ASSEMBLED BED AND THE ZIPPER WAS NOT ABLE TO BE SEPARATED. THE ISSUE COULD NOT BE REPLICATED.

    Additional Manufacturer Narrative · 0

    A REPLACEMENT CANOPY HAS BEEN SENT TO THE CUSTOMER. 250206M06 IS THE LOT FOR THE CANOPY. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE LOT PASSED ALL IN PROCESS AND FINAL INSPECTIONS. 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 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." 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. THE TECH HUB MANUAL PROVIDES THE FOLLOWING INFORMATION: IN THE WARNINGS SECTION ON PAGE 3: CHECK THIS PRODUCT FOR DAMAGED HARDWARE, LOOSE JOINTS, LOOSE BOLTS OR OTHER FASTENERS, MISSING PARTS OR SHARP EDGES BEFORE AND AFTER ASSEMBLY AND FREQUENTLY DURING USE. SECURELY TIGHTEN LOOSE BOLTS AND OTHER FASTENERS. DO NOT USE PRODUCT IF ANY PARTS ARE MISSING, DAMAGED OR BROKEN. CONTACT CUBBY FOR REPLACEMENT PARTS AND INSTRUCTIONAL LITERATURE IF NEEDED. DO NOT SUBSTITUTE PARTS. ON PAGE 19 MAINTENANCE CHECKLIST: DISCONTINUE USE AND CONTACT US IMMEDIATELY IF ANYTHING IS DAMAGED OR MISSING. TECHNOLOGY HUB ZIPPER + CORD LOOP ARE INTACT AND LOCK IS SECURED. SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING, AND THE COMPANY WILL SUPPLEMENT THIS REPORT AS NECESSARY. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Additional Manufacturer Narrative · 0

    UPDATE: 032125 IS THE LOT FOR THE TECH HUB. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE LOT PASSED ALL IN PROCESS AND FINAL INSPECTIONS.

    Description of Event or Problem · 0

    PER PARENT, HER DAUGHTER IS ABLE TO TUG ON THE FABRIC AND CAUSE THE TECH HUB ZIPPER TO SEPARATE AND IS ESCAPING THE BED. THE PARENT STATED THEY REPLACED THE TECH HUB WITH THE CLOTH COVER AND HAD THE SAME ISSUE, SO THEY WENT BACK TO USING THE TECH HUB SO THAT THEY'D BE NOTIFIED. PARENT STATED LOCKS ARE IN PLACE. A VIDEO SHOWS THE CHILD IN THE BED. IN THE LAST THIRTY SECONDS OF THE VIDEO, THE CHILD IS INTERACTING NEAR THE TECH HUB. TOWARD THE END OF THE VIDEO THE VIEW ANGLE MOVES UNTIL IT IS FACING INCORRECTLY. A PICTURE SHOWS THE ZIPPER SLIDER WITH A PARTIALLY ZIPPED ZIPPER AT THE TOP OF THE TECH HUB PORTAL. NO LOCKS ARE IN PLACE IN THE PICTURE. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406484 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 250206M06 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female