FETAL SPIRAL ELECTRODE 989803137631

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-16 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.

Event Text Entries

[183552370] Serial number unknown. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[183552371] It was reported that upon removal of the scalp electrode a spot was identified and the infant developed meningitis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218950-2020-01720
MDR Report Key9836258
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-16
Date of Report2020-03-10
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ROBERT CORNING
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFETAL SPIRAL ELECTRODE
Generic NameFETAL SPIRAL ELECTRODE, SINGLE
Product CodeHGP
Date Received2020-03-16
Model Number989803137631
Catalog Number989803137631
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-16

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