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

Model Number 1840

Device Problems Sticking (1597); Positioning Problem (3009)

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

Event Date 09/25/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the cpr would not flatten from the chair position.The bed was located in the hill-rom service center.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician found the sensors were out of calibration.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician calibrated the position sensors to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE BARIATRIC BED
• 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: 4229916
• MDR Text Key: 15817119
• Report Number: 1824206-2014-02515
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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