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

Model Number P1900G006209-1

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the hydraulic manifold needed to be replaced.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.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in october 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The hill-rom technician replaced the hydraulic manifold to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating the bed went into trendelenburg on its own.The bed was located in the icu at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TOTAL CARE 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 7112650
• MDR Text Key: 95593257
• Report Number: 1824206-2017-00519
• 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: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/29/2017

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: No Information
• Device Model Number: P1900G006209-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1