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

Model Number 3200

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the right intermediate siderail is not latching.The bed was located at the account in 216.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The hill-rom technician found the siderail not latching due to the handle needing to be lubricated.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare bed components are functioning as originally designed.Make sure the head and intermediate side rails are not bent or twisted.Make sure the side rails lock correctly in the high position and you hear the latch click.Gently pull on each side rail to make sure the latch components are clean and look for obstructions.Release each side rail from the up position, and let it fall freely.The side rail should lower slowly and smoothly.Remove the center arm cover, and examine the cable routing for pinching, binding, or damage.Make sure the latch mechanism of each side rail is in good condition.Remove the side rail cover, and make sure the mounting screws are fully installed.Make sure all functions are on the caregiver control work correctly.Repair or replace the side rails as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2010-2013.It is unknown if the facility performed any other preventative maintenance on this bed.The technician lubricated the right intermediate siderail handle to resolve the issue.Based on this information, 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: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3924702
• MDR Text Key: 16449516
• Report Number: 1824206-2014-01836
• 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: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• 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: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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