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

Model Number 9080

Device Problem Device Slipped (1584)

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

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support found the brakes not holding.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.The account will order and replace the 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 brakes would not hold.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: ART OF CARE RECLINER
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 5456453
• MDR Text Key: 39238397
• Report Number: 1824206-2016-00097
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

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: 9080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2010
• 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