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

Model Number 0800

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the wheels will not lock and the bed rolled over a nurse's toe.The bed was located at the account.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The technician found the customer neglected to set the brake.The brake was not set most likely due to user error.See scanned page.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 hill-rom technician applied the brake and inserviced the account how to set the brake.Hill-rom representative confirmed with cindy burton chief nursing officer no injury took place so no clinical investigation will be performed.Based on this information, no further action is required.

• Brand Name: CLINITRON RITEHITE BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3845180
• MDR Text Key: 4660244
• Report Number: 1824206-2014-00876
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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