MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE

Model Number 989803137631

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

Serial number unknown. A follow-up report will be submitted once the investigation is complete. Initial reporting decision based on the information currently available at this time. The metal coil from the hub detached and stuck in the fetal scalp and it went unnoticed after delivery.

Event Description

The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had detached and was stuck in the fetal scalp.

Manufacturer Narrative

Phillips was informed that the product was not available for return therefore, no evaluation of the product was able to be competed. Because of this, we are considering this to be a malfunction of unknown cause/insufficient information. It was confirmed the hospital staff was not following the instructions for use. The staff was provided with additional training in the application and removal of the fetal spiral electrode.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9125203
• MDR Text Key: 162688346
• Report Number: 1218950-2019-07384
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 18055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial