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

Model Number 989803137631

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after delivery the fetal scalp electrode couldn't be removed via the normal procedure.Medical intervention in the form of an incision was required to remove the fetal scalp electrode from the infants head.

Manufacturer Narrative

D4: serial number unknown.H10:the product associated with this complaint was not able to be returned for analysis.Photos of the product were provided which highlight that the fetal scalp electrode is physically displaced likely contributing to the difficulty in the removing the fetal scalp electrode after use however, it can not be determined how the electrode became displaced.The fetal scalp electrode was removed via the assistance of an incision and the patient received appropriate medical intervention without further incident.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

H10:the reported product was sent to manufacturer for analysis.The returned device was 100% visually inspected and it was found that the needle was broken from the white hub.The functionality test could not be performed because the needle was not returned for evaluation.All the manufacturing specifications were reviewed and confirmed that material specifications or composition of material has not changed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9868378
• MDR Text Key: 186524800
• Report Number: 1218950-2020-01874
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/18/2020; 03/18/2020
• Supplement Dates FDA Received: 07/29/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention