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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE
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PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE Back to Search Results
Model Number 989803137631
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative
Serial number unknown. A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the fetal spiral electrode would not unscrew correctly from the baby's head while in the womb.
 
Manufacturer Narrative
An evaluation could not be performed as the material was discarded. This event will considered as a malfunction of unknown cause with insufficient information.
 
Event Description
The customer reported fetal spiral would not come out of baby head when unscrewing in womb. The tip did not break but the doctor had to cut the cable because it would not unscrew correctly.
 
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Brand NameFETAL SPIRAL ELECTRODE
Type of DeviceFETAL SPIRAL ELECTRODE, SINGLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8836774
MDR Text Key152502816
Report Number1218950-2019-05543
Device Sequence Number1
Product Code HGP
UDI-Device Identifier20884838007431
UDI-Public(01)20884838007431
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/29/2019 Patient Sequence Number: 1
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