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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 Positioning Problem (3009)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the patient had head injury due to of the placement of the scalp electrode.
 
Manufacturer Narrative
H10: the customer disposed of the device therefore device evaluation data is not available.The customer was provided with information on how to avoid tip breakage and what to do if it were to occur.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the customer discarded the device.
 
Event Description
The customer reported that the patient had head injury due to the placement of the scalp electrode.
 
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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
MDR Report Key10802041
MDR Text Key215075983
Report Number1218950-2020-06709
Device Sequence Number1
Product Code HGP
UDI-Device Identifier20884838007431
UDI-Public(01)20884838007431
Combination Product (y/n)N
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 10/27/2020
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 Health Professional
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received10/27/2020
Supplement Dates FDA Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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