WORKMATE? CLARIS? SYSTEM COMPUTER Z620 H700977

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-26 for WORKMATE? CLARIS? SYSTEM COMPUTER Z620 H700977 manufactured by St. Jude Medical, Inc..

MAUDE Entry Details

• Report Number: 2184149-2019-00235
• MDR Report Key: 9377774
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-26
• Date of Report: 2019-11-26
• Date of Event: 2019-11-06
• Date Mfgr Received: 2019-11-06
• Device Manufacturer Date: 2018-06-26
• Date Added to Maude: 2019-11-26
• 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: 3
• Manufacturer Contact: STEPHANIE O' SULLIVAN
• Manufacturer Street: 5050 NATHAN LANE NORTH
• Manufacturer City: PLYMOUTH MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer Phone: 6517565400
• Manufacturer G1: ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
• Manufacturer Street: ONE ST. JUDE MEDICAL DRIVE
• Manufacturer City: ST. PAUL MN 55117
• Manufacturer Country: US
• Manufacturer Postal Code: 55117
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WORKMATE? CLARIS? SYSTEM COMPUTER Z620
• Generic Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Product Code: DQK
• Date Received: 2019-11-26
• Model Number: H700977
• Catalog Number: H700977
• Lot Number: 6876798
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, INC.
• Manufacturer Address: ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-11-26