MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the fetal spiral electrodes caused serious lesions to patients.Medical staff's referring to lesions which required surgical treatments and are reporting a removal difficulty.The device was in use on a patient.There was patient harm reported.
Event or Problem Description
It was reported that the fetal spiral electrodes caused serious lesions to patients.Medical staff's referring to lesions which required surgical treatments and are reporting a removal difficulty.The device was in use on a patient.There was patient harm reported.During the last stage of labor, an electrode was applied through fetal scalp to record the fetal heartbeat.At birth, moment when with a simple electrode¿s rotation this should have been removed, they realized electrode penetrated abnormally and potentially in a dangerous way into newborn¿s scalp (potential risk of meningeal puncture).Electrode has been placed at 7:40am and newborn was born at 8:05am for a total of 25 mins¿ application.Incident required scalp incision to remove device and subsequentially sutures¿ application.After fetal scalp electrode¿s surgical removal, patient received antibiotic therapy ev with ampicillin and netylmycin for 5 days and was discharged on (b)(6) 2022.Wound, during discharge, was already healing.On (b)(6) 2022 during an outpatient checkup, head injury appeared dry without edema and without erythema.Solution was electrode removal through surgical incision.Part wasn¿t replaced nor credit has been dispensed.
Additional Manufacturer Narrative
Visual inspection of the device found that the medical facility was using a device that facilities had been notified to cease use in december 2022.This issue has been addressed with the manufacturer.The cause of the reported problem was the extraction of the electrode that left a lesion on the patient.The customer stated that the device was removed through a surgical incision and the newborn received sutures to repair the lesion.It was confirmed that the patient¿s lesion was already showing signs of healing upon discharge from the facility.

• Brand Name: FETAL SPIRAL ELECTRODE
• Common Device Name: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15519783
• Report Number: 1218950-2022-00899
• Device Sequence Number: 6028787
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• 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: 220014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 05/08/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/16/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 3 KG