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

Model Number 0800

Device Problem Improper Flow or Infusion (2954)

Patient Problem Pressure Sores (2326)

Event Date 04/23/2014

Event Type  Other  

Event Description

The caregiver reported that the bed is not fluidizing and it feels like a rock.The caregiver stated that the pt has acquired a pressure ulcer from the bed not fluidizing.The bed is located in the pt's home.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The technician performed the investigation and the pt alleges the bed is hard and causing a bed sore on sacrum area.No other info released by the account.The technician stated that after talking with the pt and evaluating the bed, found that the cause of the bed sore on the sacrum area is due to pt being pulled to the top of the bed causing the sacrum area to be on the air wall and not in the fluidization area of the bed.The unit was testing and is functioning as designed.The technician noted the plenum pressure to be slightly high at 13.8, possible diffuser board needed.The technician found the cause of the bed not fluidizing is that the microspheres were saturated and contaminated.The diffuser board was clogged (high pressure) and zone 2 and zone 4 colder fittings were broken.The cause of the broken fittings is undetermined.A hill-rom rep called the account and spoke with the pt's niece to ask about the allegation of a new pressure ulcer developing.She stated that the bed was not fluidizing due to the heat of the condo being too hot.The niece stated the pt developed a stage four pressure ulcer and was taken to the hospital.The hill-rom rep in-serviced the pt's niece that if the bed is not fluidizing correctly to immediately call hill-rom and remove the pt from the bed.The niece also stated that the heat of the condo was why the bed was not functioning as designed.Per the hill-rom user manual, poor fluidization; if fluidization is sluggish or uneven, notify your hill-rom rep.Fluidization is affected by the following: room temperature, humidity, the amount of materials, such as fluid, cells of cellular debris, which has escaped from the blood vessels and has been deposited in tissues or on tissue surfaces, restricted air circulation from blankets on the bed.The reported injury is serious in nature per fda definition.Development of pressure ulcers is multifactorial and cannot be only attributed to performance on 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.The technician replaced the diffuser board, beads, zone 2 and zone 4 colder fittings and replaced the filter sheet to resolve the issue.Based on this info, no further action is required.

• Brand Name: CLINITRON AT HOME BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3844634
• MDR Text Key: 4687027
• Report Number: 1824206-2014-01609
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• 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: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2009
• 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): Hospitalization