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

Model Number 0800

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 04/04/2014

Event Type  Other  

Event Description

The caregiver reported the pt rec'd a skin breakdown from the bed.The bed was located in the pt's home.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician went to the account and per the pt's wife, she has seen a drop in fluidization of the bed in the last month and wound of 2 x 2 1/2 inches has begun to appear in the last 3-4 weeks.No treatment info released by the account.The technician inspected the bed and found the pressure on the bed was reading 28 h2o, beads had been replaced approx five months ago.The technician found the infuser board was the cause and it was five yrs old and worn from normal wear and tear and also clogged not allowing air to flow.The pt's wife alleges the board has never been changed.The technician also found the liner tabs on the bladder were broken off due to age and normal wear and tear.The bladder had a previous repair where tape was placed and the tap had come undone also due to normal wear and tear.The bladder had a previous repair where tape was placed and the tape had come undone also due to normal wear and tear.The technician replaced the fuser board, bladder and liner to resolve the issue.A hill-rom rep called and spoke with the pt's wife to ask about the allegation of skin breakdown.The wife stated that her husband has developed a stage 4 pressure ulcer on his right buttock.Medical treatment was sought and the wound has been debris, dressings are changed every other day, and ointment is applied.The wife confirmed that this is a new wound but the pt has had pressure ulcers before.The pt is immobile from the neck down.Since the repair the bed is functioning and the pt's wound is slowly healing.The hill-rom rep in-serviced the pt's wife about excess liquid and on a proper operating environment for the clinitron bed.The reported injury is serious in nature per fda definition.Development of pressure ulcer 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.Based on this info, no further action is required.

• Brand Name: CLINITRON AT HOME
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3800534
• MDR Text Key: 21735260
• Report Number: 1824206-2014-01375
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• PMA/PMN Number: K942184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 04/04/2014

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: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/1996
• 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 Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 100