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

Model Number 0800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Date 12/15/2013

Event Type  Other  

Event Description

The consumer reported the unit was not fluidizing and the caregiver alleged the pt is experiencing skin breakdown.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 technicians investigated and spoke with the pt's nurse who stated, "bed not fluidizing called in repair for bed." pt had secondary stage 4 pressure ulcer and was hospitalized and given antibiotics and wound care treatment because, the bed was not fluidizing correctly.The hill-rom technicians inspected the bed and found there was excessive moisture in the beads due to guide from the pt and the pt being bathed in the bed.The diffuser board was also clogged due to this.Per the hill-rom user manual: to help prevent poor fluidization, use adequate absorbent material or the impervious sheet to protect the beads from excessive bodily fluid, petroleum based compounds, and silver compounds, use impervious sheets only after clinical eval.Failure to do so could cause injury or equipment damage.To maintain optimum fluidization, protect the beads from excessive fluid exposure.Failure to do so could cause injury or equipment damage.Use absorbent material beneath excessively incontinent or draining pts, or when using petroleum-based topicals or silver compounds.If necessary use the impervious sheet from hill-rom, but only after clinical eval of whether the need to reduce wound or body fluid evaporation outweighs the benefits of more airflow and sufficient bead fluidization.Per the hill-rom clinical investigation, "alleged stage 4 pressure ulcer is serious in nature.Poor fluidization was caused by pt not following user manual directions to protect the beads from fluid exposure.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." the hill-rom technicians replaced the diffuser board, beads and filter sheet to resolve the issue.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: lori daulton ; 1069 state rt 46 e; batesville, IN 47006 ; 8129312280
• MDR Report Key: 3704422
• MDR Text Key: 4264742
• Report Number: 1824206-2014-00873
• 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: 02/17/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• 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): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 57