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

Model Number 1170

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating that the patient positioning module is not setting.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technical support found the patient was on the bed while trying to set the patient positioning module.A search of the hill-rom maintenance records did not show that hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on its beds.Hill-rom technical support inserviced the customer how to set the patient positioning module to resolve the issue.Based on this info, no further action is required.

• Brand Name: CAREASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM PLUVIGNER; pluvigner ; FR
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3973246
• MDR Text Key: 16775929
• Report Number: 9615739-2014-00230
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014

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: 1170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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