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

Model Number 1900

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the power cord plug was sparking and melted, but there were no open flames.The bed was in a patient room at the account.A patient was in the bed at the time of the incident, but there was no patient/user injury reported.This report was filed in our complaint handling system as complaint number (b)(4).Hill-rom received a user facility report from the fda about this issue (b)(4).

Manufacturer Narrative

The hill-rom technician found the ground pin bent and one of the plug's blade terminals (the hot/neutral prong) was missing from the power cord.The missing prong was broken off from the molded plug and was still in the wall outlet.The most likely cause as abuse from not unplugging the bed from the wall outlet prior to moving the bed away from the wall.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2012 and 2013.It is unknown if the facility performed any other preventative maintenance on this bed.The account's mechanic replaced the bed's power cord, the wall outlet and the outlet faceplate to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE 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: 3692060
• MDR Text Key: 16595508
• Report Number: 1824206-2014-00883
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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: 02/11/2014

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: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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