MAUDE Adverse Event Report: HILL-ROM BATESVILLE TC BARIATRIC PLUS W/AIR & PULM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1840RE300

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the bed brake casters needed to be replaced.Per the hillrom 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).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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in august 2020.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the bed brake casters to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: TC BARIATRIC PLUS W/AIR & PULM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 10962240
• MDR Text Key: 220678070
• Report Number: 1824206-2020-00506
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1840RE300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2007
• 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