MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Insufficient Information (4580)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that when the fetal scalp electrode was removed, it was noticed that the entire electrode came off and there was no metal spiral at the end of the electrode.Metal was found later from baby¿s head.A consultation with the surgeon had been performed and the surgeon had the spiral removed without a separate procedure.
Additional Manufacturer Narrative
This supplemental report is created with reference to mfg report #1218950-2022-00109 with corrected information to update the registered legal manufacturing site.
Event or Problem Description
It was reported to philips that when the fetal scalp electrode was removed, it was noticed that the entire electrode came off and there was no metal spiral at the end of the electrode.Metal was found later from baby¿s head.A consultation with the surgeon had been performed and the surgeon had the spiral removed without a separate procedure.
Additional Manufacturer Narrative
The alleged malfunctioning fetal scalp electrode was requested for evaluation but has yet to arrive.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but there is no additional information available.

• Brand Name: FETAL SPIRAL ELECTRODE
• Common Device Name: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13497731
• Report Number: 1218950-2022-00109
• Device Sequence Number: 11825434
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K030691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 214503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022; 04/27/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown