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

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.

• 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 Key: 4320444
• MDR Text Key: 16306161
• Report Number: 1824206-2014-02720
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942184
• Number of Events Reported: 1
• 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 Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/26/2014
• 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 Number: 1
• Patient Age: 59 YR
• Patient Weight: 91