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

Model Number 1170

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348); Disc Impingement (2655)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating alleged that the pins of the foot board broke when the porter was pulling the bed.The porter fell and injured her spine, suffering a slip disc.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Hill-rom found the porter who was pulling the bed by the footboard fell and injured her spine.The footboard was found broken off the bed frame.Hill-rom has requested the damaged part to be returned for further investigation.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.The reported injury is serious in nature per fda definition.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

• Brand Name: CAREASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSP 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: 4961787
• MDR Text Key: 6190210
• Report Number: 9615739-2015-00235
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• 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
• Patient Outcome(s): Other