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

Model Number 3200

Device Problem Positioning Problem (3009)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the intellidrive runs in reverse when the handle s are pushed forward.The bed was located in room 7c121 at the account.There was no patient / user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Hill-rom technical support paged a service technician to repair.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unknown if the facility performed any other preventative maintenance on this bed.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: VERSACARE BED
• Type of Device: A/C BED POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4862261
• MDR Text Key: 5863967
• Report Number: 1824206-2015-00656
• 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: Other
• Type of Report: Initial
• Report Date: 05/26/2015

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: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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