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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 08/07/2018
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken.The tip of the 989803137631 fetal spiral electrode was removed from the baby's scalp.
 
Manufacturer Narrative
The product was returned for evaluation.After inspecting the material under a microscope, it is possible that the electrode was over-rotated.Microscopic inspection of the material showed no defects in the metal.
 
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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 Key7767507
MDR Text Key116559951
Report Number1218950-2018-06255
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeAS
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 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number989803137631
Device Lot Number171624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2018
Initial Date FDA Received08/09/2018
Supplement Dates Manufacturer Received08/07/2018
Supplement Dates FDA Received11/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age1 DA
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