MAUDE Adverse Event Report: HILL-ROM BATESVILLE TC BARIATRIC PLUS W/ AIR; BARIATRIC BED

Model Number P1840RE200

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the casters needed to be replaced.Per the hill-rom service manual, the totalcare® bariatric bed and totalcare® bariatric plus therapy system require an effective maintenance program.We recommend that you perform semi-annual preventive maintenance (pm) for (b)(4).Pm not only meets (b)(4) requirements but can help make sure a long, operative life for the totalcare® bariatric bed and totalcare® bariatric plus therapy system.Pm will minimize downtime due to excessive wear.Inspect the casters for proper mounting, excessive wear, or tread damage.Replace as needed.Verify proper operation of the brake system.Adjust as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in july 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The technician will replace the brake casters to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed would not lock the bed was located in room 3153 at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TC BARIATRIC PLUS W/ AIR
• Type of Device: BARIATRIC BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 7282356
• MDR Text Key: 100654906
• Report Number: 1824206-2018-00089
• Device Sequence Number: 1
• Product Code: IOQ
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/06/2018

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: No Information
• Device Model Number: P1840RE200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1