MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON RITEHITE C-8 ASSY; BED, AIR FLUIDIZED

Model Number P0800010019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician found the proportional valve needed to be replaced.The technician replaced the proportional valve to resolve the issue.The patient was evaluated by the facility staff and found to have a stage 3 wound on his left heel.The patient was being treated with calcium alginate, but is now being treated with skin-prep.The reported injury is serious in nature per fda definition.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.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017.It is unknown if the facility performed any other preventative maintenance on this bed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient developed a stage 3 wound on his left heel.The bed was located at the account.There was a patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: CLINITRON RITEHITE C-8 ASSY
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7215041
• MDR Text Key: 98070264
• Report Number: 1824206-2018-00043
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2018

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: No Information
• Device Model Number: P0800010019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2006
• 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: 71 YR
• Patient Weight: 78