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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 Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/08/2019
Event Type  Injury  
Manufacturer Narrative
Serial number unknown. A follow-up report will be submitted once the investigation is complete. Initial reporting decision based on the information currently available at this time. The metal coil from the hub detached and stuck in the fetal scalp and it went unnoticed after delivery.
 
Event Description
The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had detached and was stuck in the fetal scalp.
 
Manufacturer Narrative
Phillips was informed that the product was not available for return therefore, no evaluation of the product was able to be competed. Because of this, we are considering this to be a malfunction of unknown cause/insufficient information. It was confirmed the hospital staff was not following the instructions for use. The staff was provided with additional training in the application and removal of the fetal spiral electrode.
 
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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 Key9125203
MDR Text Key162688346
Report Number1218950-2019-07384
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeTC
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 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot Number18055
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 Received09/25/2019
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

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