MAUDE Adverse Event Report: HILL ROM HILL-ROM VERSA CARE BED

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 03/24/2016

Event Type  Injury  

Event Description

Bed alarm communication cable connection becomes damaged over time with plugging and unplugging.The connection is similar to a computer connection with the multiple prongs.As a result we have implemented a quarterly bed safety risk assessment in order to evaluate the integrity of the bed alarm/cable/plug.

• Brand Name: HILL-ROM VERSA CARE BED
• Type of Device: HILL-ROM VERSA CARE BED
• Manufacturer (Section D): HILL ROM
• MDR Report Key: 6099341
• MDR Text Key: 59900779
• Report Number: MW5065995
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2016

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention