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

Model Number ENVELLA

Device Problems Electro-Static Discharge (2149); Device Displays Incorrect Message (2591)

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

Event Date 02/17/2020

Event Type  malfunction  

Event Description

During use of the hill-rom envella bed, the baxter sigma infusion pump registered an ec341 error message and stopped infusing medication.This has happened on several different occasions on different patients.In communication with hill rom and baxter concerning this issue, it was determined that the envella beds to emit higher levels of static electricity than the baxter sigma pump is rated for.There was no remediation reported by hill rom for this issue.Baxter suggested moving the infusion pumps as far away from the bed as possible and making sure the relative humidity was at least 30%.Fda safety report id # (b)(4).

• Brand Name: HILL-ROM ENVELLA BED
• Type of Device: BED, AIR, FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 9769807
• MDR Text Key: 181634533
• Report Number: MW5093364
• Device Sequence Number: 2
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ENVELLA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2020
• 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