ARGUS EPIC 2145-3007 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2005-05-18 for ARGUS EPIC 2145-3007 * manufactured by Adac Laboratories.

Event Text Entries

[381478] Argus fork that holds the detector looks like it has fracture. Fracture is located at the end of the main arm before the forks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2916556-2005-00391
• MDR Report Key: 606366
• Report Source: 00,05
• Date Received: 2005-05-18
• Date of Report: 2005-05-18
• Date of Event: 2005-03-01
• Date Mfgr Received: 2005-04-18
• Device Manufacturer Date: 2002-10-01
• Date Added to Maude: 2005-05-26
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MARA NGUYEN
• Manufacturer Street: 540 ALDER DR
• Manufacturer City: MILPITAS CA 950357443
• Manufacturer Country: US
• Manufacturer Postal: 950357443
• Manufacturer Phone: 4084683088
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: 2916556-07/08/05-025C
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARGUS EPIC
• Generic Name: NUCLEAR MEDICINE EQUIPMENT
• Product Code: IYY
• Date Received: 2005-05-18
• Returned To Mfg: 2005-04-18
• Model Number: 2145-3007
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 596147
• Manufacturer: ADAC LABORATORIES
• Manufacturer Address: 540 ALDER DR. MILPITAS CA 95035 US
• Baseline Brand Name: ARGUS EPIC
• Baseline Generic Name: NUCLEAR MEDICINE EQUIPMENT
• Baseline Model No: 2145-3007
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-05-18