CONMED I.V. CONTROLLER S2V-60 U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-19 for CONMED I.V. CONTROLLER S2V-60 U manufactured by Conmed Corp..

Event Text Entries

[20686161] It was reported that in the off position - unit continued to infuse.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1317214-1997-00114
• MDR Report Key: 121515
• Report Source: 05,06
• Date Received: 1997-09-19
• Date of Report: 1997-08-21
• Date of Event: 1997-08-21
• Date Facility Aware: 1997-08-21
• Report Date: 1997-08-21
• Date Mfgr Received: 1997-08-21
• Device Manufacturer Date: 1996-06-01
• Date Added to Maude: 1997-09-24
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CONMED I.V. CONTROLLER
• Generic Name: I.V. CONTROLLER
• Product Code: LDR
• Date Received: 1997-09-19
• Model Number: NA
• Catalog Number: S2V-60 U
• Lot Number: 34835
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 14 MO
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 119026
• Manufacturer: CONMED CORP.
• Manufacturer Address: 310 BROAD ST. UTICA NY 13501 US
• Baseline Brand Name: CONMED I.V. CONTROLLER
• Baseline Generic Name: I.V. CONTROLLER
• Baseline Model No: NA
• Baseline Catalog No: S2V-60 U
• Baseline ID: *
• Baseline Device Family: I.V. PRODUCTS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K964844
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-09-19