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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM HILL-ROM ENVELLA BED; BED, AIR FLUIDIZED
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HILL-ROM HILL-ROM ENVELLA BED; BED, AIR FLUIDIZED Back to Search Results
Device Problem Electronic Property Issue (2928)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  Injury  
Event Description
Problem occurred in an acute care hospital setting.It was reported to pso that interference with intravenous infusion device and also with the portable cardiac telemetry monitoring device occurred when the new hill-rom envella specialty high fluidized therapy bed is turned on and in use.This happened with 2 different pts and 2 different envella beds.The interference interrupted an infusion of blood to the pt.Once the iv machine was moved away from the bed and faced towards the window, the pt was able to continue receiving blood transfusion.This is the second report of malfunctioning pumps where an envella is present.Hill-rom has been notified and waiting to hear their action.
 
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Brand Name
HILL-ROM ENVELLA BED
Type of Device
BED, AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM
batesville IN
MDR Report Key7027406
MDR Text Key92094537
Report NumberMW5073293
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/09/2017
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 Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/13/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient Weight59
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