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

Model Number 0800

Device Problem Collapse (1099)

Patient Problems Therapeutic Response, Decreased (2271); Pressure Sores (2326)

Event Date 01/09/2014

Event Type  Other  

Event Description

The customer reported the bed needs to be checked due to the pt is sinking and is getting more sores.This report was filed in our complaint handling system as (b)(4).The home health care case manager was called by the hill-rom rep to discuss the allegation of the pt developing more sores.She stated that the pt does have preexisting wounds but has developed three new stage 4 wounds.The pt is currently having wound vac treatment.She could not confirm that the bed is causing the wounds but that the pt's husband stated he does alternate her periodically.She also stated that the pt uses a pillow under body.The hill-rom rep in-serviced the rn (case manager) that extra pillows and blankets can restrict air circulation causing poor fluidization on the bed.Per hill-rom manual, poor fluidization, if fluidization is sluggish or uneven, notify your hill-rom rep.Fluidization is affected by the following: room temperature, humidity, the amount of materials, such as fluid, cells or cellular debris, which has escaped from the blood vessels and has been deposited in tissues or on tissue surfaces, restricted air circulation from the blankets on the bed.The reported injuries are serious in nature per fda definition.There was no evidence of a malfunction or a failure to meet specs.The pt/caregiver was using tucked pillows that affected the fluidization.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), disease that reduce blood flow to the skin, such as arteriosclerosis, or disease 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.

Manufacturer Narrative

The tech assessed the bed and found that it is functioning as designed.The air intake filter appeared to be dirty and clogged so the tech replaced the air intake filter.The tech stated that the caregiver had mentioned the pt developed new wounds on her left hip.When the tech arrive the bed was not fluidizing on the foot portion of the bed and he found a pillow tucked in under the pt bottom/hip area.The tech advised the caregiver to remove the pillow.After the tech replaced the intake filter and the pillow was removed from under the pt, the bed fluidized properly.The caregiver proceeded to inform the tech that the bed had not fluidized for approx two weeks.However, the caregiver did not call it in for a repair.The tech advised the caregiver that if there is any concern with the bed in the future he should immediately contact hill-rom to ensure pt comfort and prevent injury.A hill-rom rep spoke with the pt's husband to discuss the allegation of the pt developing more sores.He stated that his wife is totally disabled and is constantly on the bed.That she has developed sores that are stage 3 and 4 pressure ulcers.His wife is seen three days a week by home healthcare.

• Brand Name: CLINITRON AT HOME BED
• 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: 3644481
• MDR Text Key: 4206736
• Report Number: 1824206-2014-00328
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 01/09/2014

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: 01/09/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/1997
• 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): Required Intervention