MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AIR FLUIDIZED

Model Number P0819A

Device Problem Unintended Movement (3026)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Baxter received a report from a baxter technician stating the brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The baxter technician found both foot casters needed to be replaced.Per the hillrom service manual, it is necessary for the envella® air fluidized therapy system to have an effective maintenance program.We recommend that you do annual preventive maintenance (pm).Pm can help make sure of a long, operative life for the unit.Check that the brakes and steering operate correctly.Check that the casters are in good condition; they do not have cuts, are not worn, and have a good amount of tread.Repair or replace the part as applicable.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in april 2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced both foot casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 18685428
• MDR Text Key: 336081840
• Report Number: 1824206-2024-00194
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1