MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacture narrative: philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Phone extension provided -(b)(6).
Event or Problem Description
The customer reported that the scalp clip of the fetal electrode detached when the electrode was removed from the baby's scalp during a c-section.An x-ray was performed on the baby and the mother; however, the metal clip was not found/recovered.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips received a complaint on the fetal spiral electrode indicating that the tip was missing after being used.There is no evidence of any harm or injury to the baby or the mother in this case.Visual inspection could not be concluded as the device was not returned to philips.Based on the information available, the cause of the reported problem is known.Philips had initiated a global recall on (b)(6) 2022 (recall # z-0908-2023).Philips had asked all customers worldwide to stop this device.Clinical assessment was performed by a pms clinical expert based on the information currently available in the complaint record.It was reported the scalp clip of the fetal electrode detached when the electrode was removed from the baby's scalp during a c-section.X-rays were performed on both the mother and baby to locate the clip; however, the clip was not found.There was no harm to either patient due to the detached clip.

• 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: 18336147
• Report Number: 1218950-2023-00939
• Device Sequence Number: 8424559
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/16/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0908-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown