MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 3200

Device Problem Device Issue (2379)

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

Event Date 02/10/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the nurse call would not work.The bed was located in storage.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the communication cable was partially unplugged and the sidecom board had bent pins where the communication cable attaches.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare bed components are functioning as originally designed.Examine and test the communication junction box.Make sure the sidecom communication system feature works correctly.Examine the communication cable, include the male nad female pins in the plug.A search of the hill-rom maintenance records shoed that hill-rom performed preventative maintenance on this bed in 2012 and 2013.It is unknown if the facility performed any other preventative maintenance.The technician replaced the sidecom board to resolve the issue.Based on this info, no further action is required.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 3737925
• MDR Text Key: 4312726
• Report Number: 1824206-2014-00781
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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