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

Model Number P0819A

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

Hill-rom envella bed ordered for pressure relief for morbidly obese, immobile, ventilated patient.Electrical issue (per the communications from both baxter and hill rom is r/t static electricity) caused baxter iv pumps to shut down and restart with error message 341.This occurred with multiple pumps and could have led to interruption of critical med strips.

• Brand Name: ENVELLA AIR FLUIDIZED THERAPY BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 8090627
• MDR Text Key: 128249786
• Report Number: MW5081502
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 157