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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 Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter:phone not provided. A follow-up report will be submitted once the investigation is complete. The injury was superficial. Betadine was applied after removal of the metal piece and no permanent injury is expected.
 
Event Description
The customer reported that the fetal electrode was easily removed after a delivery. However , it was noticed that a sliver of the metal electrode was superficially stuck in the infant's head and had to be removed with a hemostat by one of the residents.
 
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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 Key9476280
MDR Text Key171605122
Report Number1218950-2019-09488
Device Sequence Number1
Product Code HGP
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot Number191062
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 Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/16/2019 Patient Sequence Number: 1
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