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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSORY MEDICAL INC CUBBY BED ENCLOSED CANOPY BED; PATIENT BED WITH CANOPY/RESTRAINTS
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SENSORY MEDICAL INC CUBBY BED ENCLOSED CANOPY BED; PATIENT BED WITH CANOPY/RESTRAINTS Back to Search Results
Model Number CUB2
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During the manufacturer's retrospective quality assessment efforts, the following feedback was noted: zipper on canopy to attach safety zipper is pulling away from canopy.The current total observed rate of occurrence encompassing all permutations of fraying canopy components is approximately 0.78%.
 
Manufacturer Narrative
The feedback described herein was noted during the manufacturer's retrospective quality assessment efforts.The current total observed rate of occurrence encompassing all permutations of fraying canopy components is approximately 0.78%.
 
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Brand Name
CUBBY BED ENCLOSED CANOPY BED
Type of Device
PATIENT BED WITH CANOPY/RESTRAINTS
Manufacturer (Section D)
SENSORY MEDICAL INC
1514 blake st.
ste., 200
denver 80202
Manufacturer (Section G)
SENSORY MEDICAL INC
1514 blake st.
ste., 200
denver CO 80202
Manufacturer Contact
caleb polley
1514 blake st.
ste., 200
denver, CO 80202
8559642664
MDR Report Key16066381
MDR Text Key308540105
Report Number3020824629-2022-00010
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510(K)-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCUB2
Device Catalogue NumberCUB2
Device Lot Number322001
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNO 21 USC 360I(F) ACTION
Patient Sequence Number1
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