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

Model Number	989803137631
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to philips that skin tissue was removed the patient when removing the electrode.Skin tissue was removed and the lesion was disinfected and the bleeding was stopped.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that skin tissue was removed the patient when removing the electrode.
Additional Manufacturer Narrative
Skin tissue was removed and the lesion was disinfected and the bleeding was stopped.The customer returned 9 unused devices that were part of the same lot for evaluation.The devices were visually inspected under magnification for damage and defects at the electrode hub.No abnormalities were observed.A torque test was performed on all devices and the peak insertion torque was found to be within the specification.No needles were found to be bent or deformed after removal.No visual defects were found on the provided samples.Based on the investigation performed , philips determined that there is no product malfunction, no product defect, and no record of deviations during a product history review.No further actions were taken and none are warranted.

• 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: 13634646
• Report Number: 1218950-2022-00167
• Device Sequence Number: 2187299
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Operator of Device: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 214461
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown