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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 01/25/2016

Event Type  malfunction  

Event Description

Rn answered patient call light.Patient was found with right lower leg caught in recliner chair.The recliner was opened and indentations, bruising, and a slight abrasion was noted to right shin area.Patient was assessed by primary nurse.

• Brand Name: ART OF CARE RECLINER
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): HILL-ROM; 1069 state route 46 east; j34; batesville IN 47006
• MDR Report Key: 5642879
• MDR Text Key: 44793008
• Report Number: 5642879
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: SP 13598350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 85