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

Model Number ENVELLA

Device Problems Failure to Deliver (2338); Device-Device Incompatibility (2919); Environmental Compatibility Problem (2929)

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

Event Date 01/10/2020

Event Type  Injury  

Event Description

Pumps stop infusion.Here is the breakdown i provided our clinicians during this issue.Right now we cannot use the hillrom envella beds with the baxter pumps because they will not infuse.Baxter does not have a resolution.Situation: when we use the hillrom envella bed in any of our units they cause additional static electricity that shorts the baxter sigma puts out causing them to stop infusing.Background: the hill rom envella bed uses an air fluidized therapy as part of their would therapy surface, because the bed is continuously pushing air through the beds surface it dries the area around it out causing an increase in static electricity that is made worse by the dry conditions of winter.Due to the decrease in humidity and the increase of static electricity this causes the pump to error out and stop infusing.Assessment: we reached out to the hill rom reps to see if a different bed is offered but unfortunately this is the only bed of its kind.We also reached out to baxter to find out if there is a fix or a workaround for this issue, they provided the attached documentation but do not have a resolution.Their assessment is that the environment based on out flooring needs to be at 30% humidity or above and the beds needs to be properly grounded, both of these conditions are satisfied yet we continue to have this issue.The newest version of the baxter sigma pump is better insulated and can withstand additional static electricity, the new esd rating for the air is 16kv while the current version of pump that we have is only rated up to 6kv but may still run into the same issues.(b(6) reached out to baxter as well and they recommended that we do not have two versions of baxter sigma pumps throughout the hospital.(b)(6) mentioned that we would need different drug library¿s and it would take a large amount of time to get new pumps set up.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: 9706257
• MDR Text Key: 180096673
• Report Number: MW5092961
• 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: No Information
• Type of Report: Initial
• Report Date: 02/10/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENVELLA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention