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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM CLINITRON BED; AIR FLUIDIZED BED
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HILL-ROM CLINITRON BED; AIR FLUIDIZED BED Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pressure Sores (2326)
Event Date 03/15/2016
Event Type  Injury  
Event Description
We purchased a clinitron bed from hill-rom for our father in (b)(6) 2013, due to stage iii-iv bed sores.Since then, we have had ongoing problems with the bed and it is completely non-functioning now.In (b)(6) of this year, we reached out again to hill-rom because the bed was not working and our father was started to get and still has bed sores.A wound care specialist has been coming to provide care for our father but his bed sores are getting worse.He also has 24/7 nurse care.Yesterday, a hill-rom technician came to look at the bed, stated to the nurse that the temperature of the house was unacceptable (21 celsius) and left.Clearly, a bed should be able to function properly in a temperature of 69.8 fahrenheit for an elderly patient.When a different technician visited in march, i spoke with him.He stated that clinitron has always had problems and the product that we purchased was discontinued by hill-rom.We also noticed that the fda issued a compliance letter to hill-rom as early as 2012, prior to our purchase of the bed or knowledge of problems.Our father's health is being compromised by virtue of worsening bed sores and hill-rom's failure to fix the bed.
 
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Brand Name
CLINITRON BED
Type of Device
AIR FLUIDIZED BED
Manufacturer (Section D)
HILL-ROM
MDR Report Key5646257
MDR Text Key44905209
Report NumberMW5062181
Device Sequence Number1
Product Code INX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/06/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age91 YR
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