FETAL GUARD FTLGRD 3000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-16 for FETAL GUARD FTLGRD 3000 * manufactured by Air Shields - Vickers.

Event Text Entries

[15483777] Pt presented in labor and was assessed in triage using fetal monitor. Fetal monitor strip showed fetal heart tones 150-160. Pt admitted and moved to another room with another fetal monitor. This monitor also showed fetal heart tones at 150-160 with occasional breaks where rate dropped to 70-80's which was assessed as maternal heart rate. Rate always returned to 150's. Physician came in to deliver baby. He ruptured bag of water and applied fetal scalp electrode - no heart rate was attainable by monitor or doptone. An emergency c-section was done with delivery of stillborn male. Autopsy reported baby had been dead in utero for up to 48 hours prior to delivery. Fetal monitors apparently were doubling maternal rate for fetal heart tone. Monitors under warranty and removed from service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 199239
• MDR Report Key: 199239
• Date Received: 1998-11-16
• Date of Report: 1998-11-16
• Date of Event: 1998-11-03
• Date Facility Aware: 1998-11-03
• Date Reported to FDA: 1998-11-16
• Date Reported to Mfgr: 1998-11-16
• Date Added to Maude: 1998-12-01
• 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: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: FETAL GUARD
• Generic Name: FETAL MONITOR
• Product Code: HEL
• Date Received: 1998-11-16
• Returned To Mfg: 1998-11-13
• Model Number: FTLGRD 3000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 193547
• Manufacturer: AIR SHIELDS - VICKERS
• Manufacturer Address: 330 JACKSONVILLE ROAD HATBORO PA 190402211 US
• Baseline Brand Name: FETALGUARD 3000
• Baseline Generic Name: FETAL MONITOR
• Baseline Model No: IP10-E-104
• Baseline Catalog No: UNK
• Baseline ID: *

Device Sequence Number: 2

• Brand Name: FETALGUARD
• Generic Name: FETAL MONITOR
• Product Code: HEL
• Date Received: 1998-11-16
• Returned To Mfg: 1998-11-13
• Model Number: FTLGRD 3000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 193548
• Manufacturer: AIR SHIELDS - VICKERS
• Manufacturer Address: 330 JACKSONVILLE ROAD HATBORO PA 190402211 US
• Baseline Brand Name: FETALGUARD 3000
• Baseline Generic Name: FETAL MONITOR
• Baseline Model No: IP10-E-104
• Baseline Catalog No: UNK
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1998-11-16