MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The tip of the fetal spiral electrode broke off in the patient's scalp requiring additional procedures.The issue was in clinical use at the time the issue discovered.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The reported problem was confirmed via customer feedback.Based on the information available, philips was unable to replicate the reported problem due to access to the device.The device was not operational after single usage of product.The investigation concluded that no further action is required at this time.The complaint was filed two months after a recall (recall # reference (b)(4)) for the product.The recall was sent to the third party supplier (medline industries) on november 18, 2022.The incident occurred on (b)(6) 2023.The end user should have been notified by the philips vendor to be aware of any issues in regards to the fetal spiral electrode recall.It is the third party supplier¿s obligation to notify and gather all recalled items and dispose or return of the said devices to which they purchased.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16257811
• Report Number: 1218950-2023-00056
• Device Sequence Number: 17480393
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CR 2022-CC-HPM-061
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown