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

Model Number 1900

Device Problems Device Alarm System (1012); Connection Problem (2900)

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

Event Date 01/20/2014

Event Type  malfunction  

Event Description

The technician reported the nurse call cable is not able to connect, no nurse call function.The bed is located in the bed shop at the facility.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The technician found the communication cable has bent pins.Per the hill-rom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Check for current leakage at the nurse call system communication connections.Warning: a communication cable must be used for beds that have nurse call.Failure to do could cause pt injury.For beds that have nurse call systems, a communication cable must be connected between the bed and facility communication system.The technician replaced the communication cable to resolve the issue.Based on this info, no further action is required.

• Brand Name: TOTAL CARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3700888
• MDR Text Key: 4228449
• Report Number: 1824206-2014-00468
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• 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
• Date Manufacturer Received: 01/20/2014
• 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