KENEX 350 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-08 for KENEX 350 * manufactured by Kenex (electro-medical) Ltd..

Event Text Entries

[437144] Technician was lightly tugging on ceiling-mounted leaded glass screen in order to move it to a desirable working location. Seconds later it came crashing down next to her. The ceiling mounted stanchion had fatigued where it supports the vertical arm of the screen/arm system. System was installed and supplied by seimens, but they are not the manufacturer. Pm was done on 2/23/06.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 692325
• MDR Report Key: 692325
• Date Received: 2006-03-08
• Date of Report: 2006-03-08
• Date of Event: 2006-02-27
• Report Date: 2006-03-08
• Date Reported to FDA: 2006-03-08
• Date Added to Maude: 2006-03-29
• 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: KENEX
• Generic Name: SUSPENSION SYSTEM, XRAY SHIELD
• Product Code: EAK
• Date Received: 2006-03-08
• Model Number: 350
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 681474
• Manufacturer: KENEX (ELECTRO-MEDICAL) LTD.
• Manufacturer Address: 24 BURNT MILL HARLOW, ESSEX CM ** US

Device Sequence Number: 2

• Brand Name: SIEMENS MULTISTAR
• Generic Name: XRAY SYSTEM, CARDIAC CATH
• Product Code: IZI
• Date Received: 2006-03-08
• Model Number: G5419
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 681475
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Address: 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US

Device Sequence Number: 3

• Brand Name: SIEMENS MULTISTAR
• Generic Name: XRAY SYSTEM, CARDIAC CATH
• Product Code: IZI
• Date Received: 2006-03-08
• Model Number: G2182
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 681476
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Address: 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-03-08