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

Model Number P0800010016

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Pressure Sores (2326)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

The patient's existing pressure ulcer progressed to a stage 4, the mother was unsure of the prior stage, on one buttock.The patient receives wound care twice per month, with his parents providing continual in-home care.The wounds are being treated with alginate bandages and the patient is also taking oral antibiotics for the wound's infection.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 technician found the blower and electrical box needed to be replaced.The technician replaced the blower and electrical box to resolve the issue.Based on this information, no further action is required.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.It is unknown if the account performed any other preventative maintenance on this bed.

Event Description

Hill-rom received a report from the account alleging the patients wounds have gotten worse.The bed was located at the patients 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: 6158106
• MDR Text Key: 61887658
• Report Number: 1824206-2016-00524
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942184
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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
• Date Manufacturer Received: 11/17/2016
• 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 Age: 32 YR
• Patient Weight: 64