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

Model Number P0800010016

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pressure Sores (2326)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Hill-rom confirmed the patient remained on the bed while it was not working and that the patients family placed a non hill-rom air mattress on top a few days after the malfunction.The account stated that the patients health has been declining for some time now, due to his over all diagnosis.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 hill-rom technician found the blower, diffuser board, microspheres and air cushions needed to be replaced.The technician replaced the blower, diffuser board, microspheres and air cushions to resolve the issue.Based on this information, no further action is required.Per the hill-rom user manual, poor fluidization; if fluidization is sluggish or uneven, notify your hill-rom representative.Fluidization is affected by the following: room temperature, humidity, the amount of materials, such as fluid, cells or 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 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.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2013.It is unknown if the facility performed any other preventative maintenance on this bed.

Event Description

Hill-rom received a report from the account stating the patient developed a new stage 4 pressure ulcer on his buttocks.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6898139
• MDR Text Key: 87586817
• Report Number: 1824206-2017-00400
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/15/2017

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: Lay User/Patient
• Device Model Number: P0800010016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 09/27/2017
• 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: 32 YR
• Patient Weight: 82