Spiral Fetal Scalp Electrode CNS000004Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814247020505), received between Feb 21, 2018 and Dec 21, 2018 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K030691); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2018Material Fragmentation; Material Fragmentation

  A PIECE OF SCALP ELECTRODE HAS BEEN REMOVED FROM THE HEAD OF A CHILD (PP+7). THIS HAS BEEN DONE BY THE PEDIATRIC SURGEON. NORMALLY THIS SHOULD HAVE COME OUT COMPLETELY WHEN LOOSENING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8191385 ↗
• MalfunctionNov 21, 2018Device Contamination with Chemical or Other Material

  BOY WAS DELIVERED IN VAGINAL BIRTH DATE (B)(6) 2018. REMAINING INDURATIONS ON THE HEAD OF THE BABY AT SITE OF THE FETAL SCALP ELECTRODE. SUSPECTING INFECTION. ULTRASOUND RESULTS (B)(6) 2018 IMPLIED SUSPICION OF FOREIGN OBJECT. AFTER A SMALL SURGERY INCISION, IT WAS POSSIBLE TO REMOVE THE REMAINING PIECE OF THE ELECTRODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097542 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem

  USE OF GOLDTRACE FSE CLAIMED TO HAVE PERMANENTLY CAUSED TISSUE DAMAGE TO PATIENT.

  Patient problems: Tissue Damage

  MAUDE report 8016924 ↗
• InjurySep 12, 2018Connection Problem

  SPONTANEOUS PARTUS (B)(6) 2018, IN WHICH TWO TIMES A NEW SCALP ELECTRODE WAS PLACED BECAUSE OF BAD REGISTRATION. ON (B)(6) CONSULTATION IN PEDIATRICS CONCERNING INFLATED SWELLING ON THE OCCIPUT OF THE NEONATE. ULTRASOUND WAS DONE: NO CORPUS ALIENUM, BUT PUS VISIBLE. INFECTION TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 7871563 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem

  THE GOLDTRACE ELECTRODES HAVE AT MULTIPLE OCCASIONS CAUSED UNUSUALLY DIFFICULT MARKS IN THE SCALP IN RECENT MONTHS. THE BLOOD FLOW WHERE THE ELECTRODE WAS STUCK HAD TO BE SEWN ON ONE OF THE CHILDREN. AND 2 CHILDREN HAVE HAD AN INFECTION THAT LED TO AN ABSCESS. THE ABSCESS HAD TO BE OPENED AND THE CHILD HAS RECEIVED AN ANTIBIOTIC CURE. OTHER CAUSES OF BLOOD FLOW AND INFLAMMATION HAVE NOT BEEN FOUND.

  Patient problems: Abscess

  MAUDE report 7871562 ↗
• InjuryAug 14, 2018Break; Material Fragmentation; Difficult to Remove; Defective Device; Material Fragmentation

  REPORTING A BROKEN SCALP ELECTRODE THAT WAS USED FOR INTERNAL FHR MONITORING DURING CHILD BIRTH. THE DEFECTIVE SCALP ELECTRODE BREAKS WHEN REMOVING THE SCALP ELECTRODE. THE TIP OF THE SCALP ELECTRODE REMAINS UNDER THE SKIN OF THE BABY'S HEAD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7782791 ↗
• InjuryAug 14, 2018Break

  INFORMATION FROM THE PARENTS: A SCALP ELECTRODE WAS APPLIED ON THE SCALP OF MY CHILD. BECAUSE OF BRADYCARDIA DURING CONTRACTIONS. NEED TO MONITORING RISK OF FETAL HYPOXIA. THE (B)(6) 2018 (D12), A SUDDEN TUMEFACTION OF 2CM APPEARED ON THE OCCIPITAL PART WITH, AT THE SUMMIT, A SMALL CRUST CORRESPONDING TO THE ELECTRODE POSITIONING. THE (B)(6) 2018 (D16), THE TUMEFACTION IS BIGGER (2,5 CM) WITH A PURULENT FLOW. DIAGNOSIS: UNDER SKIN ABSCESS WITH STAPHYLOCOCCUS INOCULATED BY SCALP ELECTRODE MONITORING PER PARTUM. BROKEN FETAL SCALP ELECTRODE UNDER THE SKIN CAUSED TUMEFACTION WITH A PURULENT FLOW.

  Patient problems: Abscess; Device Embedded In Tissue or Plaque; Purulent Discharge; Staphylococcus Aureus; Swelling

  MAUDE report 7781977 ↗
• MalfunctionJul 20, 2018Break; Entrapment of Device

  BABY WAS DELIVERED IN VAGINAL BIRTH (B)(6). REMAINING INDURATIONS ON THE HEAD OF THE BABY AT SITE OF THE FETAL SCALP ELECTRODE. SUSPECTING INFECTION. ULTRASOUND RESULTS (B)(6) 2018 IMPLIED SUSPICION OF FOREIGN OBJECT. AFTER A SMALL SURGERY INCISION, IT WAS POSSIBLE TO REMOVE THE REMAINING PIECE OF THE ELECTRODE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7706987 ↗
• MalfunctionFeb 21, 2018Sticking

  HAD A CALL FROM (B)(6) REPORTING AN INCIDENT LAST NIGHT WHERE A GOLDTRACE SCALP ELECTRODE GOT STUCK AND HAD TO BE REMOVED SURGICALLY FROM THE BABY'S HEAD. UNFORTUNATELY THE ELECTRODE (LOT NUMBER 171214) HAS BEEN THROWN AWAY. WE ARE AWAITING MORE DETAILED INFORMATION FROM THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 7287243 ↗
• MalfunctionFeb 21, 2018Break; Detachment Of Device Component

  ON THE (B)(6) 2018 A MIDWIFE APPLIED A SCALP ELECTRODE DURING DELIVERY (FULLY DILATED). THE ELECTRODE IMMEDIATELY BROKE OFF AT THE FIRST MOVEMENT OF APPLICATION. FORTUNATELY SHE IMMEDIATELY NOTICED THIS AND REPORTED THE INCIDENT TO THE PEDIATRICIAN. THE PEDIATRICIAN MADE AN X-RAY OF THE SKULL OF THE BABY ON THE (B)(6) 2018. IT INDEED APPEARED THAT THE ELECTRODE WIRE WAS STILL UNDER THE SKIN. YOU CANNOT FEEL IT ON THE BABY'S HEAD, BUT IT WILL BE REMOVED IN CONSULTATION WITH THE DOCTOR AND THE PLASTIC SURGEON.

  Patient problems: Foreign Body In Patient

  MAUDE report 7287240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030691. One submission often covers many models, so check the product and lot details in each record.

• Z-0908-2023 · Nov 21, 2022 · Open, Classified
  Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
• Z-1250-2019 · Jan 25, 2019 · Terminated
  Fetal Spiral Electrode, Model No. 9898 031 37631