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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON AT HOME; BED, AIR-FLUIDIZED

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HILL-ROM, INC. CLINITRON AT HOME; BED, AIR-FLUIDIZED Back to Search Results
Model Number 0800
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problems Injury (2348); Impaired Healing (2378)
Event Date 10/31/2014
Event Type  Injury  
Event Description
The patient's wife reported that her husband's wounds were getting worse and he developed a new wound.The patient is a double amputee at the pelvis.The account stated that the bed alarmed and shut down and then they contacted hill-rom.The technician evaluated the unit and found the part needed was not in stock and let the account know.The account then placed the patient on a non-hill-rom mattress for 7 days, until the repair could be completed.The account treated the wounds with silvadene and two types of antibiotics.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the blower was inoperative.The technician replaced the blower and the issue was resolved.The reported injury is serious in nature per fda definition.However, the deterioration of the pressure ulcer took place while the patient was not on a hill-rom surface.Development of pressure ulcers is multifactorial and cannot be only attributed to performance of the surface.Risk factors include protein-calorie malnutrition, microclimate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy.Position changes are key to pressure sore prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.
 
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Brand Name
CLINITRON AT HOME
Type of Device
BED, AIR-FLUIDIZED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4320444
MDR Text Key16306161
Report Number1824206-2014-02720
Device Sequence Number1
Product Code INX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942184
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model Number0800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/31/2014
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age59 YR
Patient Weight91
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