MAVIG OT25U50 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-04 for MAVIG OT25U50 * manufactured by Ti-ba Enterprises, Inc..

Event Text Entries

[1314369] Patient was draped and prepped for a procedure. Md went to adjust the suspended lead shield into position and the suspension arm broke from the ceiling mount suspension system. Md was hit on arm with shield, but managed to catch the shield. Patient field intact, patient unharmed. Md denies injury at this time. The arm was installed as part of our siemens axiom artis system in one of our angio rooms. The break occurred on the arm directly above the joint (not on the joint itself). Where the break occurred, you could see that the arm had dings and other markings made by impact with other equipment. It should be noted that there was a sticker on the arm (placed by the company) that states that impact with equipment could weaken the structure of the arm. We thought that this might indicate that there had been previous issues. When we installed a new arm, we made sure to alter the position of the arm so that it no longer hits other equipment on a frequent basis. The equipment manufacturer happened to be on sight for other maintenance, when this occurred. They were able to quickly remove the broken arm and install the new arm the next day. We have never had a similar break before. If we had realized that this was a possibility we would have considered it into our design plan. It was our good luck that the arm fell away from the sterile field, and that the doctor was able to catch it. The arm is much heavier than it looks, and the torn edge was very jagged.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1587423
• MDR Report Key: 1587423
• Date Received: 2010-01-04
• Date of Report: 2010-01-04
• Report Date: 2010-01-04
• Date Reported to FDA: 2010-01-04
• Date Added to Maude: 2010-01-27
• 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: MAVIG
• Generic Name: LEAD SHIELD, CEILING SUSPENDED
• Product Code: KPY
• Date Received: 2010-01-04
• Returned To Mfg: 2009-12-31
• Model Number: OT25U50
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: R
• Device Age: 5 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TI-BA ENTERPRISES, INC.
• Manufacturer Address: 25 HYTEC CIRCLE ROCHESTER NY 14606 US 14606

Device Sequence Number: 2

• Brand Name: AXIOM ARTIS
• Generic Name: X-RAY SYSTEM, CATH/ANGIO
• Product Code: IZI
• Date Received: 2010-01-04
• Model Number: 6134-824-G122E
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 5 YR
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Address: 51 VALLEY STREAM PKWY. MALVERN PA 19355 US 19355

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-01-04