HILL-ROM ENVELLA BED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for HILL-ROM ENVELLA BED manufactured by Hill-rom, Inc..

Event Text Entries

[180096673] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092961
MDR Report Key9706257
Date Received2020-02-12
Date of Report2020-02-10
Date of Event2020-01-10
Date Added to Maude2020-02-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameHILL-ROM ENVELLA BED
Generic NameBED, AIR FLUIDIZED
Product CodeINX
Date Received2020-02-12
Model NumberENVELLA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM, INC.

Device Sequence Number: 2

Brand NameBAXTER SIGMA SPECTRUM INFUSION PUMP
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-02-12
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-02-12

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