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

Model Number P0800010016

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician evaluated the bed and found the fluidization was within normal range and operating properly.A phone interview was conducted with complainant (b)(4).Stated that her brother is a paraplegic brittle diabetic patient with a history of st6ge 4 decubiti of the left and right ischium area.He is bedridden, however for the past two months has been going to the wound clinic weekly via a stretcher and also receives hbot therapy.She also reported that the patient receives a high protein diet and repositions himself from side to side frequently.(b)(6) indicated the clinitron mattress is very hard from the patient's buttocks to his waist.She stated she does not believe the bed itself has caused the decubiti as the stretcher her brother is placed on for transport weekly for wound care is very hard.She wants to ensure the bed is working the best it can to help heal and prevent further decubiti.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.

Event Description

Hill-rom received a report from the account stating the patient developed redness over the sacral area that developed into 2 quarter sized stage 4 decubiti.The patient was located at their home.This report was filed in our complaint handling system as complaint #(b)(4).

• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 5722704
• MDR Text Key: 47354042
• Report Number: 1824206-2016-00256
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2016

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: P0800010016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/14/2016
• 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 Outcome(s): Other