INNOVANCE PFA-200 SYSTEM 10488536

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-03 for INNOVANCE PFA-200 SYSTEM 10488536 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

MAUDE Entry Details

• Report Number: 9610806-2019-00047
• MDR Report Key: 8577793
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-05-03
• Date of Report: 2019-05-03
• Date of Event: 2019-04-03
• Date Mfgr Received: 2019-04-12
• Date Added to Maude: 2019-05-03
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. BENLEY SAINT-JEAN
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN NY 10591
• Manufacturer Country: US
• Manufacturer Postal: 10591
• Manufacturer Phone: 9145242398
• Manufacturer G1: BIT ANALYTICAL INSTRUMENTS GMBH
• Manufacturer Street: REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3
• Manufacturer City: SCHWALBACH, 65824
• Manufacturer Country: GM
• Manufacturer Postal Code: 65824
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INNOVANCE PFA-200 SYSTEM
• Generic Name: INNOVANCE PFA-200 SYSTEM
• Product Code: JOZ
• Date Received: 2019-05-03
• Model Number: INNOVANCE PFA-200 SYSTEM
• Catalog Number: 10488536
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
• Manufacturer Address: EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-03