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

Model Number P0819A

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Specialty bed stopped functioning.Bed was rebooted and functioning correctly.Patient was off bed less than 50 minutes.Manufacturer response for specialty bed, hill rom envella bed (per site reporter) hill rom and tech assisted to reboot the system.

• 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: 11667016
• MDR Text Key: 245506665
• Report Number: 11667016
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

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 Operator: Health Professional
• Device Model Number: P0819A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1