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

Model Number 0800

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

The patient has 3 preexisting stage 2 wounds that he thinks have progress to stage 3.Patient receives home health visits 3 times a week, the same as before this issue.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 bed was not fluidizing due to multiple reasons, the liner had a hole, air bladder was worn, blower was not powering on correctly due to excessive use over time, diffuser board was extremely clogged due to excessive use over time, filter extremely clogged from excessive use over time, and the beads had failed the bead test due to excessive use over time.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 did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Hill-rom technician replaced the replaced the blower, intake filter, filter sheet, air wall bladder, diffuser seal, bladder bottom cover, beads, diffuser board to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patients wounds were getting worse.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: CLINITRON BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5427955
• MDR Text Key: 37999123
• Report Number: 1824206-2016-00076
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/18/2016

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: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/10/2016
• 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