ELSCINT AI 3310 CTM/W EXTENSION NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-05-31 for ELSCINT AI 3310 CTM/W EXTENSION NA manufactured by Del Medical Imaging.

Event Text Entries

[270426] Telescoping arm detached from support cable allowing arm to descend to fully open position.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1418964-2002-00002
• MDR Report Key: 397880
• Report Source: 08
• Date Received: 2002-05-31
• Date of Report: 2002-05-31
• Date of Event: 2002-05-06
• Date Mfgr Received: 2002-05-06
• Device Manufacturer Date: 1987-03-01
• Date Added to Maude: 2002-06-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Contact: ANDREW HRYNDZA
• Manufacturer Street: 11550 W. KING STREET
• Manufacturer City: FRANKLIN PARK IL 60131
• Manufacturer Country: US
• Manufacturer Postal: 60131
• Manufacturer Phone: 8472887000
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ELSCINT
• Generic Name: CEILING MOUNT TELESCOPING TUBE MOONT
• Product Code: IYB
• Date Received: 2002-05-31
• Returned To Mfg: 2002-06-06
• Model Number: AI 3310 CTM/W EXTENSION
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 386927
• Manufacturer: DEL MEDICAL IMAGING
• Manufacturer Address: 11550 WEST KING ST. FRANKLIN PARK IL 60131 US
• Baseline Brand Name: ELSCINT
• Baseline Generic Name: CEILING MOUNT TELESCOPING TUBE MOONT
• Baseline Model No: AI 3310 CTM/W E
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-05-31