HILL-ROM VERSACARE PATIENT HELPER ADAPTER * 00-0965-000-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-25 for HILL-ROM VERSACARE PATIENT HELPER ADAPTER * 00-0965-000-00 manufactured by Zimmer , Inc..

Event Text Entries

[787906] Hospital purchased hill-rom versa care beds for use on a newly opening trauma specialty care unit. We had a need for traction patient assist brackets for the new beds. ( hill-rom publishes a document of traction accessories available from other vendors for the versa care bed on their website @ hill-rom. Com ) we purchased the zimmer patient helper bracket/bar assembly only to find out once they were installed on the beds that there is an inherent safety problem with the bracket set up. This helper bar slides into a tube attached to the head of the bed and is secured by a hand knob at an adjustment clamp, allowing you to vary the height of the bar assembly above the patient. If you attempt to adjust the bar by loosening the hand clamp, and you are not holding onto the bar, it will slam down towards the patient's head. There is a potential for serious injury. The other problem identified; as the bar slams down, the metal on the bar gets shaved, if you will , to a point of having very sharp burrs left on the bar. Those burrs could cause cuts to caregivers hands or anyone who tries to get the bar off the bed. ====================== manufacturer response for traction patient assist bar, hill-rom versacare patient helper adapter======================initially they indicated there was no type of saftey lock or stop available and that when we adjusted the bar we had to hold on to it. Today we had a rep from zimmer come in to see our concern first hand, we gave him a little demo of the slaming down of the bar on an empty bed, and showed him the shaved metal burrs on the bar afterwards.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 997626
• MDR Report Key: 997626
• Date Received: 2008-01-25
• Date of Report: 2008-01-25
• Date of Event: 2008-01-07
• Report Date: 2008-01-25
• Date Reported to FDA: 2008-01-25
• Date Added to Maude: 2008-02-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: HILL-ROM VERSACARE PATIENT HELPER ADAPTER
• Generic Name: TRACTION ASSIST SYSTEM
• Product Code: ILZ
• Date Received: 2008-01-25
• Model Number: *
• Catalog Number: 00-0965-000-00
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 966490
• Manufacturer: ZIMMER , INC.
• Manufacturer Address: 345 EAST MAIN STREET WARSAW IN 46580 US

Device Sequence Number: 2

• Brand Name: VERSA CARE BED
• Generic Name: BED, HOSPITAL
• Product Code: FNL
• Date Received: 2008-01-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 966491
• Manufacturer: HILL-ROM COMPANY, INC.
• Manufacturer Address: 1069 STATE ROAD 46 EAST; MAIL BATESVILLE IN 470069167 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-01-25