MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BARIATRIC; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1840

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating that the side rail would not latch.The bed was located at the account.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The technician found the side rail pin was out of place.This bed is a rental unit and is subject to between patient inspections which includes the pin activities.The technician attached the side rail pin to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE BARIATRIC
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3896308
• MDR Text Key: 4648121
• Report Number: 1824206-2014-01552
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/24/2014

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: 1840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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