ICON 5220327 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-07-22 for ICON 5220327 * manufactured by Siemens Medical Systems.

Event Text Entries

[157451] Inconsistent results may occur when saving oblique data multiple times from the processing page while in the autoperfusion program.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423253-1999-00012
• MDR Report Key: 233338
• Report Source: 07
• Date Received: 1999-07-22
• Date of Report: 1999-07-08
• Date of Event: 1999-07-07
• Date Mfgr Received: 1999-07-08
• Date Added to Maude: 1999-07-29
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ICON
• Generic Name: COMPUTER
• Product Code: JWM
• Date Received: 1999-07-22
• Returned To Mfg: 1999-03-01
• Model Number: 5220327
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 226177
• Manufacturer: SIEMENS MEDICAL SYSTEMS
• Manufacturer Address: 2501 BARRINGTON RD. HOFFMAN ESTATES IL 60195 US
• Baseline Brand Name: ICON
• Baseline Generic Name: COMPUTER
• Baseline Model No: 5220327
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-07-22