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

Model Number P0800010016

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician informed the account that hill-rom no longer services this device.The patient was hospitalized for treatment when a third ulcer opened; the new ulcer is a stage 3.The patient's ulcers are on his buttocks and are being treated daily by a nurse.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.Per the hill-rom user manual, poor fluidization; if fluidization is sluggish or uneven, notify your hill-rom representative.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 blankets on the bed.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unknown if the facility performed any other preventative maintenance on this bed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient developed a new wound.The bed was located at the patient's 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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 6493268
• MDR Text Key: 72837179
• Report Number: 1824206-2017-00173
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 03/22/2017

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: Other Caregivers
• Device Model Number: P0800010016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1