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

Model Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

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

Event Type  malfunction  

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%.

Event Description

During the manufacturer's retrospective quality assessment efforts, the following feedback was noted: the seam of the mesh door is coming apart creating a large hole.The current total observed rate of occurrence encompassing all permutations of fraying canopy components is approximately 0.78%.

• 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: 16066375
• MDR Text Key: 308481440
• Report Number: 3020824629-2022-00007
• 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
• 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 Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 11015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• 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