BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23009673 · Received September 9, 2025

    Report

    Report Number
    3016541541-2025-00063
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    May 19, 2025
    Report Date
    September 9, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: THE PARENT REPORTED THE CHILD HAD A SCRAPE FROM THE ZIPPER. HEALTH EFFECT CLINICAL CODE HAS BEEN CORRECTED FROM 4580 TO 1689. HEATLH EFFECT IMPACT CODE HAS BEEN CORRECTED FROM 4648 TO 4613.

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL FOLLOWED UP ON AUGUST 11, 13, 15 (CALL), 18TH, 2025, WHERE SOME QUESTIONS INCLUDING INQUIRIES FOR PICTURES, CLARITY ON THE EVENT, RETURN OF PRODUCT, AND IF THERE WERE ANY INJURIES WERE ANSWERED BY THE COMPLAINANT ON AUGUST 18TH, 2025, AND FURTHER REQUESTS FOR INFORMATION WERE REQUESTED AUGUST 19, 22, AND 25, 2025. ALL COMMUNICATIONS WERE VIA EMAIL UNLESS OTHERWISE SPECIFIED. THE CAREGIVER ELECTED TO INSTALL AND USE COMPONENTS ON THE BED THAT WERE NOT APPROVED OR SUPPLIED BY THE MANUFACTURER. THIS ACTION WAS TAKEN CONTRARY TO THE INSTRUCTIONS AND LIMITATIONS SPECIFIED IN THE USER MANUAL, WHICH CLEARLY STATE THAT ONLY MANUFACTURER-APPROVED PARTS AND ACCESSORIES ARE PERMITTED FOR SAFE USE. 15607 IS THE LOT FOR THE PADLOCK AND S-CLIPS. 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. "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 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE 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. 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." 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

    UPDATE: THE PARENT REPORTED THE CHILD HAD A SCRAPE FROM THE ZIPPER.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT THEIR SON WAS ABLE TO ELOPE 6 TIMES IN THE FIRST TWO WEEKS OF HAVING THE CUBBY BED, INCLUDING THE SAFETY SHEET. PER PARENT, THE SON EXPLAINED TO THEM THAT HE WAS ABLE TO POP OFF THE LOCKS OR UNSNAP THE S-CLIPS TO ESCAPE. THE PARENT MENTIONED THE LOCK ON THE SAFETY SHEET ZIPPER SPECIFICALLY. THE PARENT REPORTED THEY BOUGHT NON-CUBBY LOCKS AND CARABINIER CLIPS THAT THEY ARE CURRENTLY USING. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841009 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 15607 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male