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

Model Number 989803137631

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the newborn developed scalp ulceration at the site of philips scalp electrode.The device was reported to be in use on a patient, the baby developed scalp ulceration.

Event Description

It was reported to philips that the newborn developed scalp ulceration at the site of philips scalp electrode.The device was reported to be in use on a patient, the baby developed scalp ulceration.

Manufacturer Narrative

A good faith effort was made to get the device associated with this complaint back for evaluation, but there is no additional information available as the reported part was scrapped by the customer.Based on the investigation, there is insufficient data available to determine the actual cause of the incident.The customer reported that they switched back to their original distributor (3rd party device).No further actions were taken and none are warranted.

• 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 ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 12513824
• MDR Text Key: 272733333
• Report Number: 1218950-2021-10953
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization