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

Model Number 0800

Device Problems Ambient Temperature Problem (2878); Device Operates Differently Than Expected (2913); Moisture or Humidity Problem (2986)

Patient Problems Incontinence (1928); Necrosis (1971)

Event Date 11/25/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account alleging the pt has a pre-existing stage 2 sacral wound that progressed to a stage 4.The wound care nurse stated an incision was made to remove the necrotic tissue and the wound has been receiving daily antibiotic ointment treatments along with cleaning with saline solution and the use of aqua seal silver dressing.The bed was located in the pt's home.This report was filed in our complaint handling system as complaint # (b)(4).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 pt.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.

Manufacturer Narrative

The hill-rom technician found the micro spheres were over saturated with moisture and needed to be replaced.The technician replaced the microspheres to resolve the issue.The reported injury is serious in nature per fda definition.Moisture in beads was not related to a malfunction of the device.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.

• 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: 4372881
• MDR Text Key: 5263186
• Report Number: 1824206-2014-02882
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• 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: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 60 YR
• Patient Weight: 54