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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL ROM / CLINITRON RITE HITE; FLUIDIZED THERAPY BED
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HILL ROM / CLINITRON RITE HITE; FLUIDIZED THERAPY BED Back to Search Results
Model Number RITE HITE
Device Problems Leak/Splash (1354); Device Emits Odor (1425); Particulates (1451)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2015
Event Type  malfunction  
Event Description
The medical center was renting a clinitron air fluidized therapy bed for this pt.The mattress contains tiny, grade silicone coated beads mixed with air to provide their unique mattress pressure.The pt and nursing staff made complaints about dust in the air and a slippery floor while using this bed for a couple of hours until they realized that the dust was actually the tiny beads from the mattress of the specialized bed and that the mattress must somehow be compromised.This bed bead leak created a hazardous environment for pt and staff, with the floor covered in tiny microbeads and the air reportedly had a "strange smell".While neither pt nor staff was harmed in this incident, there were safety concerns about the safety and future use of this type of rental bed in the medical center.The bed was rented for this pt from hill rom.It was returned to the rental vendor hill rom.
 
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Brand Name
RITE HITE
Type of Device
FLUIDIZED THERAPY BED
Manufacturer (Section D)
HILL ROM / CLINITRON
chicago IL
MDR Report Key4905647
MDR Text Key6538615
Report NumberMW5043902
Device Sequence Number1
Product Code INX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2015
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRITE HITE
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight84
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