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 Code	Abrasion (1689)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that fetal scalp electrode was difficult to remove.Before removing fse, the metal part of the electrode had to realign to the normal position causing wound on the skin surface which is bit bigger than normal.
Additional Manufacturer Narrative
This supplemental report is created with reference to mfg report #1218950-2021-10993 with corrected information to update the registered legal manufacturing site.

• 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: 13839822
• Report Number: 1218950-2022-00230
• Device Sequence Number: 13703092
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 214092
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2022
• 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: Male
• Patient Weight: 459 KG