MAUDE Adverse Event Report: HILL-ROM BATESVILLE CENTURY BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P837

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician and facility administrator inspected and evaluated the bed and found no malfunction.The patients toe had the circulation cut off and not able to be saved.The injury to the toe resulted in amputation.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed form 2007-2012.It is unknown if the facility performed any other preventative maintenance on this bed.

Event Description

Hill-rom received a report from the account stating the patient put his leg in between the head and foot side rails during the night and the nurses found him in the morning.The nurses had to rotate the rail to free his leg.The bed was located in room 212 bed a at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: CENTURY BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 5135418
• MDR Text Key: 27809172
• Report Number: 1824206-2015-00947
• 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,user f
• Reporter Occupation: Other
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: P837
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other