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 01/06/2014

Event Type  malfunction  

Event Description

The tech reported the brake was not holding.No pt injury reported.

Manufacturer Narrative

The tech did not find a cause for the brake caster not holding.The tech replaced the brake caster assembly to resolve the issue based on this info, 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: jennifer morris ; 1069 state route 46 e; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3819019
• MDR Text Key: 4403778
• Report Number: 1824206-2014-00270
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/06/2014

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: 01/06/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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