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 08/26/2014

Event Type  Injury  

Event Description

Hill-rom received a report form the account stating that the patient had a pre-existing stage 4 wound on his coccyx and began air fluidized therapy.The patient complained that the microspheres were not fluidizing and the wound had healed to the size of a quarter and now it has increased to the size of a golf ball.The bed was located in the home.This report was filed in our complaint handling system as (b)(6).

Manufacturer Narrative

The hill-rom technician found the plenum pressure was good but the microspheres were worn.The hill-rom technician replaced the microspheres to resolve the issue.Pressure ulcer was pre-existing but was progressing to be larger.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), disease that reduce blood flow to the skin, such as arteriosclerosis, or disease that reduce the sensation in the skin, such as paralysis or neuropathy.Position 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 wear of microspheres to the point that they will not fluidize properly is multifaceted and their replacement is a practical occurrence that is inherent with use of the bed.Several factors come into account, environment, use and care of the patient.Hill-rom recommends not exceeding an ambient room temperature of 75 degrees f.The microspheres can handle limited amounts of fluids passing through the filter sheet.Excessive humidity, incontinence and bodily fluids will saturate the beads and hamper fluidization.Treatment from caregivers such as petroleum based topical ointments and silver compounds will ruin the coating on the beads and permanently destroy their fluidizing properties.

• 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: 4155941
• MDR Text Key: 4772263
• Report Number: 1824206-2014-02348
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• 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
• Date Manufacturer Received: 09/16/2014
• 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: 79 YR