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

Model Number CUB2

Device Problem Mechanical Problem (1384)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Complainant contacted the firm to allege that the bed rolls everywhere even when the wheels are locked.Complainant alleges that this user runs back and forth inside the bed and keeps banging into the wall.Complainant alleges that it takes one hard push and the user hits the wall with his head.

• Brand Name: CUBBY TECHNOLOGY HUB
• 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: 16001108
• MDR Text Key: 308177309
• Report Number: 3020824629-2022-00003
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CUB2
• Device Catalogue Number: CUB2
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 12/17/2022
• 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 Number: NO 21 USC 360I(F) ACTION
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic