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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
Serial number unknown. A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a baby required sutures to its head following removal of the fetal spiral electrode. Patient outcome is unknown at the time of this report.
 
Manufacturer Narrative
A return material authorization has been provided to the customer for the return of the fetal spiral electrode for evaluation. As of the date of this report, no material has been received for evaluation. If material is received for evaluation, the complaint can be reopened to add evaluation details. The material was not available for further evaluation. Because of this, we are considering this to be a malfunction of unknown cause/insufficient information.
 
Event Description
The customer reported a baby required sutures to its head following removal of the fetal spiral electrode. No additional information has been provided.
 
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Brand NameFETAL SPIRAL ELECTRODE
Type of DeviceFETAL 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 Key9357032
MDR Text Key174726960
Report Number1218950-2019-08892
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989803137631
Device Lot Number191064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2019
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 Initial

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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