REMISOL ADVANCE VIRTUALIZED SERVER 2012 C05231

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-08 for REMISOL ADVANCE VIRTUALIZED SERVER 2012 C05231 manufactured by Normand-info S.a.s.u.

MAUDE Entry Details

• Report Number: 3006543086-2019-00001
• MDR Report Key: 9169992
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-10-08
• Date of Report: 2019-10-08
• Date of Event: 2019-09-10
• Date Mfgr Received: 2019-09-10
• Date Added to Maude: 2019-10-08
• 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: MS. CHRISTINE XARDEL
• Manufacturer Street: 7 RUE FREDERIC DEGEORGE BAT B 2 IEME ETAGE
• Manufacturer City: ARRAS
• Manufacturer G1: NORMAND-INFO S.A.S.U
• Manufacturer Street: 7 RUE FREDERIC DEGEORGE BAT B 2 IEME ETAGE
• Manufacturer City: ARRAS, ARRAS PAS-DE-CALAIS 62028
• Manufacturer Country: FR
• Manufacturer Postal Code: 62028
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: REMISOL ADVANCE VIRTUALIZED SERVER 2012
• Generic Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Product Code: JQP
• Date Received: 2019-10-08
• Model Number: REMISOL ADVANCE VIRTUALIZED SERVER 2012
• Catalog Number: C05231
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NORMAND-INFO S.A.S.U
• Manufacturer Address: 7 RUE FREDERIC DEGEORGE BAT B 2 IEME ETAGE ARRAS PAS-DE-CALAIS 62028 FR 62028

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-08