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

Model Number P0800010016

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

Patient Problem No Code Available (3191)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

The patient had a preexisting surface wound on his buttocks that tunneled to the bone.The hill-rom technician found a draw string that was loose, causing the filter sheet seam to rise up.This seam is located at the head end of the fluidization portion of the sleep surface and would be located where the patients back would be laying.Per the hill-rom user manual, positioning the patient (page 25): placing the patient on the unit; lower the head end of the unit to 0° (see "raising and lowering the head end" on page 25).Caution, before removing the side rails, slide the release latches toward the head end of the unit to unlock the side rails.Failure to do so could result in equipment damage.Slide the side rail release latches toward the head end of the unit, and lift the side rails up and away from the unit.Before placing the patient on the bed, lay a flat bed sheet on the unit.Do not tie the flat bed sheet down or tuck it in.Help the patient onto the unit, and place the patient with his or her waist on the air-wall cushion next to the beads and his or her buttocks in the beads.To ensure that the patient floats freely in the beads, pull the filter sheet from each side.Ensure that the filter sheet and the flat bed sheet stay loose.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The patients wound is being treated by dressings at the attention of his home healthcare.The technician pushed the filter sheet back down in the bed to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patients wounds have worsened.The bed was located at the account.There was a patient injury reported.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: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5508095
• MDR Text Key: 40597066
• Report Number: 1824206-2016-00125
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Type of Report: Initial
• Report Date: 02/17/2016

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: 02/17/2016
• Initial Date FDA Received: 03/17/2016
• 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