BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUBBY BED

    MDR report key: 18414161 · Received December 28, 2023

    Report

    Report Number
    3016541541-2023-23371
    Event Type
    Death
    Date Received
    December 28, 2023
    Date of Event
    December 12, 2022
    Report Date
    December 20, 2023
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS MADE SEVERAL ATTEMPTS TO GATHER IMAGES OF THE DAMAGED PRODUCT AND GAIN ACCESS TO THE PRODUCT ITSELF, BUT HAS NOT OBTAINED OR GAINED ACCESS THESE ITEMS. THEREFORE, THE MANUFACTURER HAS BEEN UNABLE TO CONFIRM THE REPORTED DAMAGE GENERALLY OR THE NATURE OF ANY DAMAGE THAT MIGHT HAVE OCCURRED TO THE TECH HUB PORTAL ZIPPER AND/OR THE TECH HUB HOUSING. THE MANUFACTURER IS CONTINUING TO SEEK TO HAVE THE PRODUCT RETURNED OR TO GAIN ACCESS TO IT FOR EVALUATION. INVESTIGATION INTO THE EVENT TO DATE HAS INCLUDED: REVIEW OF THE LABELING THAT WAS PROVIDED TO THE CARETAKERS, IN THIS INSTANCE THE PARENTS. REVIEW OF PRIOR COMMUNICATION WITH THE FAMILY. REVIEW OF MANUFACTURING RECORDS FOR THE CUBBY BED SAFETY BED AND TECH HUB (WITH NO NONCONFORMITIES FOUND). ATTEMPTS TO RECREATE THE REPORTED CAUSES. GATHERING OF FURTHER INFORMATION FROM THE COMPLAINANT AND LOCAL AUTHORITIES. THE INVESTIGATIVE EFFORTS THUS FAR DID NOT IDENTIFY AN AREA WHERE PREVIOUSLY ESTABLISHED SPECIFICATIONS AND CONTROLS WERE INADEQUATE NOR DID THESE EFFORTS THUS FAR IDENTIFY A GAP IN CURRENT PROCESS FOR CUBBY BEDS QUALITY AND/OR MANUFACTURING PROCESSES. THE MANUFACTURER HAS TAKEN RISK CONTROL MEASURES WITH THE PRODUCT. THE BED'S TECH HUB OPENING HAS A COVER THAT IS ZIPPED CLOSED WHEN THE TECH HUB IS NOT INSTALLED ON THE BED. THE ZIPPER PULL IS LOCATED ON THE OUTSIDE OF THE BED. A LOCK IS PROVIDED FOR THE OPENING. IF THE TECH HUB IS PRESENT, IT WILL FILL THE OPENING AND BE SECURED WITH A LOCK. THE TECH HUB AND BED ARE MADE OF HIGH QUALITY AND DURABLE MATERIALS INTENDED FOR THE ENCLOSED BED ENVIRONMENT. FINALLY, PRODUCT LABELING CARRIES WARNINGS INTENDED TO SPECIFICALLY GUARD AGAINST HEAD AND NECK ENTRAPMENT THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE MANUFACTURER IS SUBMITTING THIS REPORT 1 DAY LATER THAN THE REQUIRED 30 DAY WINDOW DUE TO TECHNICAL ISSUES WITH THE FDA SUBMISSION PORTAL; THOSE HAVE NOW BEEN RESOLVED WITH FDA STAFF.

    Description of Event or Problem · 0

    USER REPORTEDLY BECAME ENTRAPPED IN THE CUBBY BED'S TECHNOLOGY HUB PORTAL AFTER REPORTEDLY DAMAGING THE TECHNOLOGY HUB'S HOUSING & THE CUBBY BED'S CANOPY OPENING. THE TECHNOLOGY HUB PORTAL ZIPPER ALSO REPORTEDLY SEPARATED. THE REPORTED CAUSE OF DEATH WAS ASPHYXIA DUE TO HANGING (ENTRAPMENT OF HEAD AND NECK). NOTE: THIS EVENT WAS REPORTED TO SENSORY MEDICAL INC. ON 20 NOVEMBER 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360832 CUBBY BED PATIENT BED WITH CANOPY/RESTRAINTS OYS SENSORY MEDICAL INC. N/A #1417 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Death