MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P0819A

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found the assy diffuser was clogged and dirty and 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.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on 12/11/2020.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the assy fabric diffuser to resolve the issue.Despite multiple attempts to obtain further clinical information from the customer, hillrom is not able to determine if serious injury had occurred, therefore, hillrom is conservatively reporting this complaint as a serious injury.Based on this information, no further action is required.

Event Description

Hillrom received a report from a customer stating that the bed was not fluidizing.The bed was located at the account.The patients bed sores looked worse.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ENVELLA BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12228396
• MDR Text Key: 263558380
• Report Number: 1824206-2021-00390
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411190102
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2018
• 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
• Patient Outcome(s): Other