MAUDE Adverse Event Report: SENSORY MEDICAL INC CUBBY BED ENCLOSED CANOPY BED; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number CUB2

Device Problems Break (1069); Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2022

Event Type  malfunction  

Event Description

The center support bar of a 170 lb.Genetic/biological male user's bed frame gave way under load resulting in a depression in the middle aspect of the mattress.

• 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 Key: 16040596
• MDR Text Key: 306835115
• Report Number: 3020824629-2022-00004
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CUB2
• Device Catalogue Number: CUB2
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NO 21 USC 360I(F) ACTION
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American