NAVIG ARM OT25U50 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-09 for NAVIG ARM OT25U50 * manufactured by Mavig Suspension System.

Event Text Entries

[15614097] While pt was undergoing cardiac catheterization, the mavig arm, part of the siemens axion artis biplane cardiac cath lab system, broke near its horizontal rotation joint and fell from the ceiling. It struck the nursing assistant in the head causing a 2cm, forehead laceration.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040922
• MDR Report Key: 780803
• Date Received: 2006-11-09
• Date of Report: 2006-11-09
• Date of Event: 2006-11-02
• Date Added to Maude: 2006-11-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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 Details

• Brand Name: NAVIG ARM
• Generic Name: SUSPENSION ARM
• Product Code: KPY
• Date Received: 2006-11-09
• Model Number: OT25U50
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 768582
• Manufacturer: MAVIG SUSPENSION SYSTEM
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-11-09