MAUDE Adverse Event Report: HILL-ROM, INC. ENVELLA¿ BED; BED, AIR FLUIDIZED

Model Number P0819A

Device Problem Leak/Splash (1354)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Envella bed arrived.Had to warm up due to the frigid temperature while the bed was in the delivery truck overnight.It took several hours.Transferred the patient over to the envella bed without a problem.The sand was leaking out of the bottom of the bed, which made the floor very slippery.Called housekeeping and the floor was mopped.In the room and where the bed was parked in the hallway.No one fell.The ap called hillrom and the delivery person is coming to determine if the bed can be fixed and used or if it has to be replace.The patient is a tranfer to 3a.

• Brand Name: ENVELLA¿ BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 16609426
• MDR Text Key: 312050925
• Report Number: 16609426
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1