MAUDE Adverse Event Report: HILL-ROM, INC. CLNITRON RITEHITE; BED, AIR FLUIDIZED

Model Number 0800

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 12/21/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating the patient developed a blister on their heel.The bed was located at the account in room 20.(b)(4).

Manufacturer Narrative

The hill-rom technician found an air hose disconnected from the bed.The patient developed a decubitus on the right heal.The sore is unstageable due to the necrotic blister.The patient is being treated with ointments and it is healing slowly.The patient is on the bed due to preexisting sores on the hip and buttocks.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.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.The technician reconnected the hose to resolve the issue.Based on this information, no further action is required.

• Brand Name: CLNITRON RITEHITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4452611
• MDR Text Key: 5395511
• Report Number: 1824206-2015-00117
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2014

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: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2014
• Initial Date FDA Received: 01/20/2015
• 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
• Patient Age: 60 YR