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

Model Number 0800

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the head right brake caster was not holding.The bed was located at a hill-rom service center not in use.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

The hill-rom technician found the brake caster not holding most likely due to normal wear and tear.The technician replaced the brake casters to resolve the issue.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 rt 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3969265
• MDR Text Key: 4611871
• Report Number: 1824206-2014-01376
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2014

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: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2001
• 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