MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS MEDICAL SYSTEMS FETAL SCALP ELECTRODE; ELECTRODE, CIRCULAR (SPINE) SCALP AND APPLICATOR

Model Number 9898 031 37631

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2019

Event Type  malfunction  

Event Description

Md was unable to affix the electrode to the fetal scalp.When applicator removed, noted no exposed spiral piece attached to the end.Further inspection revealed neither the applicator nor the tip had an opening for a spiral electrode to be affixed.Fda safety report id# (b)(4).

• Brand Name: PHILIPS MEDICAL SYSTEMS FETAL SCALP ELECTRODE
• Type of Device: ELECTRODE, CIRCULAR (SPINE) SCALP AND APPLICATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; andover MA 01810
• MDR Report Key: 8500849
• MDR Text Key: 141735356
• Report Number: MW5085747
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: 9898 031 37631
• Device Lot Number: 180361
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 65