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

Model Number P0800010019

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the front brake caster needed to be replaced.Per the hill-rom user manual, warning: patients may use the bed for support while entering or exiting; if the unit moves unexpectedly, patient injury could occur.When the unit is unattended, ensure that both brakes are locked.The brakes for the clinitron bed are located at the right, head end and the left, foot end of the unit.To apply the brakes, step on the lower end of the brake lever to lock the wheels.To release the brakes, apply inward pressure to the upper end of the brake lever.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician will replace the brake caster 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 bed brakes were not working.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(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: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8146622
• MDR Text Key: 130050757
• Report Number: 1824206-2018-00472
• 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: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P0800010019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/10/2018
• 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