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

Model Number 989803137631

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Skin Inflammation/ Irritation (4545)

Event Date 10/08/2021

Event Type  Injury  

Event Description

The customer reported that the fetal spiral electrode was placed onto the patient and was not able to remove it and resulted in a skin injury.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The device was returned to philips for evaluation.Philips sent the fetal scalp electrode (fse)to the manufacture for evaluation.The manufacture stated that visual inspection and stated that there was no defect of damaged discovered.The device was torque tested and the device meet specification.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 Description

The customer reported that the fetal spiral electrode was placed onto the patient and was not able to remove it.The patient incurred a skin injury.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: 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: 12764080
• MDR Text Key: 280454583
• Report Number: 1218950-2021-11077
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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 Operator: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 3 KG