FETAL MONITOR 118 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-17 for FETAL MONITOR 118 * manufactured by Ge Medical Systems Info Technologies.

Event Text Entries

[340563] Corometrics fetal monitor 118 - blood pressure function would not register a reading after the reading. It fluctuated around 60 [the diastolic number would stay in the 55-65 range and not complete the blood pressure process] and eventually will just not register anything else. Maintenance was notified and came to the unit to investigate. [biomed worked on the device after the problem and it seems to be functioning without any problems. It will not be returned to the mfr since it is now working fine. ] device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 508379
• MDR Report Key: 508379
• Date Received: 2003-10-17
• Date of Report: 2003-09-01
• Date of Event: 2003-07-01
• Date Added to Maude: 2004-01-29
• 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: 3
• 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: FETAL MONITOR 118
• Generic Name: FETAL MONITOR
• Product Code: KXN
• Date Received: 2003-10-17
• Model Number: 118
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 497325
• Manufacturer: GE MEDICAL SYSTEMS INFO TECHNOLOGIES
• Manufacturer Address: 8200 WEST TOWER AVE MILWAUKEE WI 532233219 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-17