MAUDE Adverse Event Report: HILL-ROM INC. CARE ASSIST; HOSPITAL BED

Device Problem Human-Device Interface Problem (2949)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Pt experienced multiple scratches and abrasions to right fore arm.Cause of skin tears due to pt lifting self up in bed using his forearms against the bed rail.Skin injury from rubbing against molded bump on lower opening on bed rail that keeps the hand-held part of bed controls in place.

• Brand Name: CARE ASSIST
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• MDR Report Key: 3862794
• MDR Text Key: 16799791
• Report Number: 3862794
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2014
• Distributor Facility Aware Date: 05/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 135