SYNGO LAB DATA MANAGER 10638933

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 2019-07-24 for SYNGO LAB DATA MANAGER 10638933 manufactured by Siemens Healthcare Diagnostics Inc..

MAUDE Entry Details

• Report Number: 2517506-2019-00297
• MDR Report Key: 8824226
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-07-24
• Date of Report: 2019-09-26
• Date of Event: 2019-06-28
• Date Mfgr Received: 2019-09-04
• Date Added to Maude: 2019-07-24
• 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: CHRISTINA LAM
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN NY 10591
• Manufacturer Country: US
• Manufacturer Postal: 10591
• Manufacturer Phone: 9145243504
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Street: 500 GBC DRIVE PO BOX 6101
• Manufacturer City: NEWARK DE 197146101
• Manufacturer Country: US
• Manufacturer Postal Code: 197146101
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYNGO LAB DATA MANAGER
• Generic Name: SYNGO LAB DATA MANAGER
• Product Code: JQP
• Date Received: 2019-07-24
• Model Number: SYNGO LAB DATA MANAGER
• Catalog Number: 10638933
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Address: 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-24