VERSA CARE P3200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-22 for VERSA CARE P3200 * manufactured by Hill-rom Company, Inc..

Event Text Entries

[789098] The patient found the traction support bars located within the frame adapter on the versa care bed. These two traction support bars (right and left) are removable. The inpatient was cognitively impaired and admitted to the psych unit. The patient came out his room holding the traction support bar in his hand. The bar could be used as a weapon. ====================== manufacturer response for bed, versa care p3200======================unknown at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 999512
• MDR Report Key: 999512
• Date Received: 2008-01-22
• Date of Report: 2008-01-22
• Date of Event: 2008-01-16
• Report Date: 2008-01-22
• Date Reported to FDA: 2008-01-22
• Date Added to Maude: 2008-02-20
• 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
• Reporter Occupation: RISK MANAGER
• 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: VERSA CARE P3200
• Generic Name: BED
• Product Code: FNL
• Date Received: 2008-01-22
• Model Number: P3200
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 11 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 968129
• Manufacturer: HILL-ROM COMPANY, INC.
• Manufacturer Address: 1069 STATE ROAD 46 EAST MAIL CODE: RITTER M-22 BATESVILLE IN 470069167 US

Device Sequence Number: 2

• Brand Name: VERSA CARE FOOT END ADAPTER
• Generic Name: ADAPTER, TRACTION FRAME
• Product Code: ILZ
• Date Received: 2008-01-22
• Model Number: P3211B
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 968130
• Manufacturer: ORTHOPEDIC SYSTEMS, INC.
• Manufacturer Address: 30031 AHERN AVE UNION CITY CA 945871234 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-01-22