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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 09/27/2019
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 a case using infant head spiral electrodes may have developed neonatal cerebrospinal fluid leakage.
 
Manufacturer Narrative
The fetal spiral electrode did not malfunction, the injury may be due to the placement of the electrode. The patient was treated with antibiotics and bandage. Phillips was informed that the product was not available. Trending shows there are no other incidents of this nature reported in the past year. The customer stated that the device was not available for evaluation.
 
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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 Key9145823
MDR Text Key162709968
Report Number1218950-2019-07514
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
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 Received10/01/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/02/2019 Patient Sequence Number: 1
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