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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 No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.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.
 
Event Description
The customer reported breakage of metal part of fetal scalp electrode during attaching the metal part to infant.
 
Manufacturer Narrative
H10: 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 product was scrapped and not made available for evaluation.
 
Event Description
The customer reported breakage of metal part of fetal scalp electrode during attaching the metal part to infant.The electrode was removed from the baby's head without any injury.
 
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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 Key10277699
MDR Text Key199467138
Report Number1218950-2020-04075
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,health professional,u
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot Number181244
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/13/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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