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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Initial reporter phone number: (b)(6).
 
Event Description
The customer reported the tip of the (b)(4) fetal spiral electrode remained under the baby's scalp during removal and was not noticed by the staff.A week later the baby was examined for a sore spot on the scalp.The metal tip was surgically removed.The patient did sustain a wound to the scalp which was treated.
 
Manufacturer Narrative
The customer reported the tip of the (b)(4) fetal spiral electrode remained under the baby's scalp during removal and was not noticed by the staff.A week later the baby was examined for a sore spot on the scalp.The metal tip was surgically removed.The patient did sustain a wound to the scalp which was treated.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.The ifu for the fse (b)(4) states in a warning not to over rotate the fse.It was reported that the customer had discarded the fse assembly and the fragment was not available for evaluation.The date of the incident was not provided.
 
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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
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6812859
MDR Text Key83367559
Report Number1218950-2017-05829
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/09/2018
Device Model Number989803137631
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2017
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? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age1 DA
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