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

Model Number	FETAL SPIRAL ELECTRODE
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to philips that a twin was born via forceps delivery.Fse was unable to be removed prior and was cut.Took forceps to remove fse after baby was delivered and on resuscitation trolley.
Additional Manufacturer Narrative
This supplemental report is created with reference to mfg report #1218950-2021-10767 with corrected information to update the registered legal manufacturing site.

• 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: 13893308
• Report Number: 1218950-2022-00252
• Device Sequence Number: 1790581
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: FETAL SPIRAL ELECTRODE
• Device Catalogue Number: 989803137631
• Device Lot Number: 213974
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 2 KG