GE FETAL MONITOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for GE FETAL MONITOR * manufactured by Ge Healthcare.

Event Text Entries

[18890951] Patient arrived for r/o labor and decreased fetal movement. When patient was put on the coro for fetal tracing, unable to detect heart tones, but could feel fetal movement. There was intermittent fetal tracing with minimal variability, which was then undetectable on the fetal tracing. Verified fetal heartbeat and bpp with ultrasound, which did not correspond with coro tracing of a flat line. Transferred patient's tracing to rover 1, which corresponded with ultrasound showing moderate variability. Note: transducer involved in this incident was not removed from service at the time the issue occurred. Transducer serial number redacted malfunctioned on the following day, creating a similar event with a different coro machine.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4794457
• MDR Report Key: 4794457
• Date Received: 2015-05-08
• Date of Report: 2015-05-08
• Date of Event: 2015-04-26
• Report Date: 2015-05-08
• Date Reported to FDA: 2015-05-08
• Date Reported to Mfgr: 2015-05-26
• Date Added to Maude: 2015-05-26
• 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
• 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: GE FETAL MONITOR
• Generic Name: FETAL MONITOR
• Product Code: HEL
• Date Received: 2015-05-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226

Device Sequence Number: 2

• Brand Name: GE TRANSDUCER
• Generic Name: TRANSDUCER
• Product Code: ITX
• Date Received: 2015-05-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-05-08