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

Model Number	989803137631
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the fetal spiral electrode difficult removal and caused a skin injury on the babies head.The device was reported to be in use on a patient, the patient suffered a skin injury.
Additional Manufacturer Narrative
Philips reached out for more information regarding the incident and to see if the product was available for return.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 fse (fetal spiral electrode) was removed from the patients by surgical intervention of the doctor.H3 other text : device not accessible for testing.
Event or Problem Description
The customer reported that the fetal spiral electrode difficult removal and caused a skin injury on the babies head.The device was reported to be in use on a patient, the patient suffered a skin injury.

• 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: 13315301
• Report Number: 1218950-2022-00058
• Device Sequence Number: 13829990
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,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
• 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: 08/02/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/04/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown