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

Model Number 0800

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating that the left brake caster would not hold.The bed was located in a hill-rom service center and not in use.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The hill-rom technician during a between patient inspection found worn brake pads preventing the brake from holding.The technician replaced the brake caster 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 route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3896310
• MDR Text Key: 21312380
• Report Number: 1824206-2014-01551
• 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: 04/23/2014

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: 04/23/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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