COROMETRICS 115 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-31 for COROMETRICS 115 * manufactured by Corometrics.

Event Text Entries

[50330] Fetal monitor shows "502" in heart rate display. No toher functions. Date/time switch enabled. Monitor was in a programming mode to set date/time. Disabled date/time switch, unit functions normally.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 81965
• MDR Report Key: 81965
• Date Received: 1997-03-31
• Date of Report: 1997-03-31
• Date of Event: 1997-03-21
• Date Facility Aware: 1997-03-21
• Report Date: 1997-03-31
• Date Reported to FDA: 1997-03-31
• Date Added to Maude: 1997-04-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COROMETRICS
• Generic Name: FETAL MONITOR
• Product Code: KNG
• Date Received: 1997-03-31
• Model Number: 115
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 12 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 81372
• Manufacturer: COROMETRICS
• Manufacturer Address: 61 BARNES PARK RD N. WALLINGFORD ON CA 06492

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-03-31