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

Model Number 0800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Pressure Sores (2326)

Event Date 04/08/2014

Event Type  Other  

Event Description

Hill-rom received a report from the account stating the bed was hard.The bed was located in room (b)(6) at the account.The account stated the pt was complaining of their buttons hurting.The nursing staff thought that the pain was due to pt's decubitus.Pt was 1st admitted with a state 1 decubitus and now has unstageable decubitus.(b)(4).The reported injury is serious in nature per fda definition.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.

Manufacturer Narrative

The account stated the bed did not alarm so there was no cause to call hill-rom to repair the bed.A staff member got into the bed to test it out since the pt was still complaining about pain and found that the bed was bottoming out.The tech investigated and found the air coupling was loose.The tech tightened the air coupling to resolve the issue.The pt has a history of squamous cell carcinoma.Admitted to the sicu (b)(6) 2014 post total laryngectomy.He had surgical wash out of esophageal fistulas and pectoral flap on (b)(6) 2014.Pt was on vasopressors and very ill.During this time he developed a diverticulum and had a colectomy.Poor nutritional status as a result of these multiple surgical procedures.On (b)(6) 2014 pt was noted to have a stage 1 decubitus on his backside.On (b)(6) 2014, decubitus was considered to have progressed to a deep tissue wound.On (b)(6) 2014, pt placed on a clinitron bed.

• Brand Name: CLINITRON RITEHITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3802977
• MDR Text Key: 4369756
• Report Number: 1824206-2014-01407
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• 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 Weight: 91