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

Model Number P1900Q007678

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative suggested that the account check the nurse cable.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 patient injury.For beds that have nurse call systems, a communication cable must be connected between the bed and facility communication system.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Three attempts have been made regarding a resolution to this contact line, with no response.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the nurse call was not working at the nurse's station, but was working on the bed.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: TOTALCARE FRAME
• 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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7333510
• MDR Text Key: 102213978
• Report Number: 1824206-2018-00113
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1900Q007678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2013
• 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