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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 Patient-Device Incompatibility (2682)
Patient Problem Abrasion (1689)
Event Date 09/05/2018
Event Type  Injury  
Manufacturer Narrative
Phone not provided. Serial number not provided. A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reports scalp lesions of newborns, from the application of fetal monitoring (scalp) during labor. The patient required administration of an antibiotic therapy for 10 days.
 
Manufacturer Narrative
It was reported that a newborn patient was born via ¿normal birth¿ and the doctor used the device before the delivery time for monitoring of the fetal heart. A month after discharge from hospital, was readmitted to the neonatal exam room for a head echography, as the newborn presented an under-cutaneous neoformation similar to an atheroma. The impression was confirmed by the results of the echography and visual-tactile examination as the cyst was mobile compared to lower layers and not painful at touch. After another month, the mother brought back the newborn to the er because some ¿substance/material¿ was oozing from the cyst. In the er the surgeon removed, with surgical tweezers, some spiral shaped metallic fragments compatible with the scalp electrode. A return material authorization was issued for the return of the device involved in the incident for evaluation. Philips was advised that the hospital team was not aware of the occurrence of the broken electrode. Therefore, the device was not retained. Additional information was requested, but the distributor was unable to confirm how this had occurred. Therefore, we are considering this a malfunction of cause unknown for reporting purposes only.
 
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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 Key8440432
MDR Text Key139462074
Report Number1218950-2019-02164
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2019
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 Initial

Patient Treatment Data
Date Received: 03/21/2019 Patient Sequence Number: 1
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