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

Model Number	989803137631
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Abrasion (1689); Needle Stick/Puncture (2462)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
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 was placed onto the patient and was not able to remove it.The device was reported to be in use on a patient, and the patient suffered a skin injury.
Additional Manufacturer Narrative
The device was returned to philips for evaluation.Philips then sent the fetal scalp electrode to the manufacture for evaluation.The manufacture stated that visual inspection of the device discovered no defects or damage to the device.The device was torque tested and was found to meet the device specification.No needles were found to be bent or deformed after removal.Following delivery, the fse was attempted to be removed from the scalp of the infant.The cord was cut and unraveled in attempt at removal.It was noted that the spiral tip was retained in the scalp and immediately removed by pediatrician using sterile technique.
Event or Problem Description
The customer reported that the fetal spiral electrode was placed onto the patient and was not able to remove it.The device was reported to be in use on a patient, and 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: 13179260
• Report Number: 1218950-2022-00010
• Device Sequence Number: 20047884
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: 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: 193835
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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