MAUDE Adverse Event Report: HILL-ROM INC. TOTALCARE BARIATRIC PLUS BED; AC POWERED ADJUSTABLE HOSPITAL BED

Model Number 1840

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

The account reported the brakes are loose.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The technician found the brakes are out of adjustment.This probably caused by normal wear and tear.The technician adjusted the brake casters to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE BARIATRIC PLUS BED
• Type of Device: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3893563
• MDR Text Key: 4541947
• Report Number: 1824206-2014-00460
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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