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

Model Number 0800

Device Problem Inflation Problem (1310)

Patient Problem Impaired Healing (2378)

Event Date 05/08/2014

Event Type  Other  

Event Description

The caregiver reported the bed is not fluidizing well enough in the sacral area where the patient's wound is and the wound is getting worse.The bed was located in the patient's home.(b)(4).A hill-rom representative spoke with the patient's wife, and she stated that her husband has pre-existing wounds (pressure ulcers) that did get worse when the bed was not fluidizing due to the issue of the bed getting fluid spilled in it.Her husband did see his physician that put him back on the wound vac that he had gotten off of when the wounds were improving.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.The technician replaced beads to resolve the issue.Based on this information, no further action is required.

Manufacturer Narrative

The technician investigated and found the beads are not fluidizing due to moisture in the beds from water being spilled on the bed.To maintain optimum fluidization, protect the beads from excessive fluid exposure.Failure to do so could cause injury or equipment damage.Use absorbent material beneath excessively incontinent or draining patients, or when using petroleum-based topicals or silver compounds.If necessary, use the impervious sheet from hill-rom, but only after clinical evaluation of whether the need to reduce wound or body fluid evaporation outweighs the benefits of more airflow and sufficient bead fluidization.

• Brand Name: CLINITRON RITEHITE 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: 3878076
• MDR Text Key: 4564161
• Report Number: 1824206-2014-01731
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• 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: 05/08/2014

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: 05/08/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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: 60 YR
• Patient Weight: 68