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

Model Number	989803137631
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported during a gesture, the spiral electrode shifted in relation to the support.The installation and the extraction of the device was carried out with difficulty.Harm was reported to the child.
Event or Problem Description
The customer reported during a gesture, the fetal spiral electrode shifted in relation to the support.The installation and extraction of the device were carried out with difficulty.The device was in patient use at the time of the event.It was reported that there was harm to the patient¿s heart.It was later that the customer confirmed the patients did not need any other medical intervention to resolve their issue.Philips reached out for more information regarding the incident and to see if the product was available for return.The customer confirmed that there was no harm to the patient.Unfortunately, we did not receive any material back for evaluation.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.The defective device was not available for evaluation.No evaluation could be completed to confirm the device issue.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15230038
• Report Number: 1218950-2022-00718
• Device Sequence Number: 4785062
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 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

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
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 214879
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/17/2022
• 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: Required Intervention
• Patient Sex: Unknown