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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 Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/13/2018
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.Further information about this incident is pending.
 
Event Description
The customer reported that the spiral tip of the fetal spiral electrode (b)(4)) had broken.The tip of the (b)(4) fetal spiral electrode was removed from the baby's scalp.
 
Manufacturer Narrative
The returned material was visually inspected under a microscope.The remaining portion of the spiral tip showed it had been bent.There were no defects in the metal.The microscopic inspection of the electrode indicates the electrode was over rotated causing the tip to break off.
 
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Brand Name
FETAL SPIRAL ELECTRODE
Type of Device
FETAL 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 Key7515284
MDR Text Key108293908
Report Number1218950-2018-04347
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number989803137631
Device Lot Number171588
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age1 DA
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