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 09/26/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the bed will not go into cpr.The bed was located 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

The hill-rom technician support found the head motor to be inoperable.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2009-2011.It is unknown if the facility performed any other preventative maintenance on this bed.The account ordered and will replace the head motor to resolve the issue.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

• 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: 4229915
• MDR Text Key: 5077372
• Report Number: 1824206-2014-02519
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• 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