MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Death
Additional Manufacturer 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.
Event or Problem Description
It was reported fetal monitoring was difficult and there was a loss of signal during epidural insertion, requiring placement of a fetal scalp electrode.Once in place, the monitor generated a coincidence alarm for 20 minutes between the fetal and maternal heart rates.Following the vaginal birth, the baby was brought to the nicu but could not be resuscitated and subsequently passing away.There were no complications during delivery and autopsy of the baby was pending.The customer did not believe there should have been a coincidence when using a fetal scalp electrode.The electrode was discarded, and the monitors sequestered.
Additional Manufacturer Narrative
Philips received a complaint on the fetal spiral electrode indicating that fetal monitoring was difficult and there was a loss of signal during epidural insertion, requiring placement of a fetal scalp electrode.Once in place, the monitor generated a coincidence alarm for 20 minutes between the fetal and maternal heart rates.Following the vaginal birth, the baby was brought to the nicu but could not be resuscitated and subsequently passing away.There were no complications during delivery and autopsy of the baby was pending.The customer did not believe there should have been a coincidence when using a fetal scalp electrode.The electrode was discarded, and the monitors sequestered.It was noted in the user report that the fetal spiral electrode was discarded and is therefore unavailable for evaluation.Multiple attempts were made to obtain additional information regarding the event, with no response from the customer.No further information was provided.Based on the information available, the cause of the reported problem was not able to be established.The reported problem was not confirmed based on the information available, no further action is necessary at this time.A review of the global decision tree was performed, and the issue was deemed reportable.Any report of an actual death where a philips device was used is considered reportable since the use of the device may have been a factor in the death.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The reported device was discarded by the customer; therefore, analysis was not able to be performed and investigation has been completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19561822
• Report Number: 1218950-2024-00446
• Device Sequence Number: 12649862
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown