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

Model Number 0800

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the patient stating their pre-existing stage 4 sacral wound is getting worse.The patient complained that the microspheres were not fluidizing and now he has to be scheduled for flap surgery.The bed was located in the home.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician inspected the bed and found the diffuser board and air flow valve needed to be replaced.The technician replaced the diffuser board and air flow valve to resolve the issue.Developement 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.As the wounds have worsened, the patient is now scheduled for flap surgery.

• Brand Name: CLINITRON AT HOME
• 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: 4379095
• MDR Text Key: 5239498
• Report Number: 1824206-2014-02867
• Device Sequence Number: 1
• Product Code: INX
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/22/2014
• 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 Age: 46 YR
• Patient Weight: 77