MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number 989803137631

Device Problem Separation Failure (2547)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2021

Event Type  Injury  

Event Description

It was reported to philips that a twin was born via forceps delivery.Fse was unable to be removed prior and was cut.Took forceps to remove fse after baby was delivered and on resuscitation trolley.There was a delay in delivery.

Manufacturer Narrative

A good faith effort was made to get the part back for evaluation associated with this complaint evaluation, but there is no additional information available.The reported part was scrapped by the customer.Per the customer the baby had not returned to the hospital with any issues.No further actions were taken and none are warranted.H3 other text : the reported part was scrapped by the customer.

Event Description

It was reported to philips that a twin was born via forceps delivery.Fse was unable to be removed prior and was cut.Took forceps to remove fse after baby was delivered and on resuscitation trolley.

Manufacturer Narrative

This supplemental report is created with reference to mfg report #1218950-2021-10767 with corrected information to update the manufacturing site.H3 other text : the reported part was scrapped by the customer.

Event Description

It was reported to philips that a twin was born via forceps delivery.Fse was unable to be removed prior and was cut.Took forceps to remove fse after baby was delivered and on resuscitation trolley.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12258649
• MDR Text Key: 264478278
• Report Number: 1218950-2021-10767
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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
• Device Lot Number: 213974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Other