MAUDE Adverse Event Report: HILL-ROM BATESVILLE BARIATRIC RECLINER; CHAIR AND TABLE, MEDICAL

Model Number P9095A0001037

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the casters level washers needed to be replaced.Per the hill-rom service manual recommends semi-annual function and cosmetic checks to make sure the product remains in good working order.The function check should include inspecting assembly fasteners and tightening as needed.If the recliner has a gas spring, check for proper function and adjust as needed.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this unit.It is unknown if the facility performs preventative maintenance on their units.The technician replaced the casters level washers 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 complaint (b)(4).

• Brand Name: BARIATRIC RECLINER
• Type of Device: CHAIR AND TABLE, MEDICAL
• 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: 11013098
• MDR Text Key: 223833151
• Report Number: 1824206-2020-00519
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P9095A0001037
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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