Fetal Measurements FETAL SPIRAL ELECTRODERecalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 20884838007431), received between Mar 21, 2019 and Jun 18, 2024 — classified as 1 death, 74 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 21, 2022Class IIOpen, Classified

   Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

   Z-0908-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• DeathJun 18, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED FETAL MONITORING WAS DIFFICULT AND THERE WAS A LOSS OF SIGNAL DURING EPIDURAL INSERTION, REQUIRING PLACEMENT OF A FETAL SCALP ELECTRODE. ONCE IN PLACE, THE MONITOR GENERATED A COINCIDENCE ALARM FOR 20 MINUTES BETWEEN THE FETAL AND MATERNAL HEART RATES. FOLLOWING THE VAGINAL BIRTH, THE BABY WAS BROUGHT TO THE NICU BUT COULD NOT BE RESUSCITATED AND SUBSEQUENTLY PASSING AWAY. THERE WERE NO COMPLICATIONS DURING DELIVERY AND AUTOPSY OF THE BABY WAS PENDING. THE CUSTOMER DID NOT BELIEVE THERE SHOULD HAVE BEEN A COINCIDENCE WHEN USING A FETAL SCALP ELECTRODE. THE ELECTRODE WAS DISCARDED, AND THE MONITORS SEQUESTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561822 ↗
• MalfunctionMay 23, 2024Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED A FETAL SPIRAL ELECTRODE WAS USED DURING LABOR ON THIS KNOWN RECALLED PRODUCT. THE SCALP ELECTRODE WAS REMOVED BUT THE METAL CLIP WAS DETACHED; THEREFORE, AN X-RAY OF THE BABY'S SCALP POST C-SECTION WAS PERFORMED BUT THE METAL CLIP WAS NOT PRESENT. THE MOTHER WAS ALSO X-RAYED AND THERE WAS NO METAL CLIP PRESENT. THE CLIP WAS NOT RECOVERED AS IT WAS NOT FOUND. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388788 ↗
• MalfunctionDec 15, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SCALP CLIP OF THE FETAL ELECTRODE DETACHED WHEN THE ELECTRODE WAS REMOVED FROM THE BABY'S SCALP DURING A C-SECTION. AN X-RAY WAS PERFORMED ON THE BABY AND THE MOTHER; HOWEVER, THE METAL CLIP WAS NOT FOUND/RECOVERED. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336147 ↗
• InjuryJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIP OF THE FETAL SPIRAL ELECTRODE BROKE OFF IN THE PATIENT'S SCALP REQUIRING ADDITIONAL PROCEDURES. THE ISSUE WAS IN CLINICAL USE AT THE TIME THE ISSUE DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16257811 ↗
• InjurySep 30, 2022Insufficient Device Problem Information; Difficult or Delayed Separation; Insufficient Device Problem Information; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE FETAL SPIRAL ELECTRODES CAUSED SERIOUS LESIONS TO PATIENTS. MEDICAL STAFF'S REFERRING TO LESIONS WHICH REQUIRED SURGICAL TREATMENTS AND ARE REPORTING A REMOVAL DIFFICULTY. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 15519783 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DURING A GESTURE, THE SPIRAL ELECTRODE SHIFTED IN RELATION TO THE SUPPORT. THE INSTALLATION AND THE EXTRACTION OF THE DEVICE WAS CARRIED OUT WITH DIFFICULTY. HARM WAS REPORTED TO THE CHILD.

  Patient problems: Insufficient Information

  MAUDE report 15230038 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE IS CAUSING BLEEDING LACERATIONS ON FETAL HEAD REQUIRING REPAIR. THE DEVICE WAS IN USE AT TIME EVENT AND IT WAS REPORTED THAT THE PATIENT HAS SKIN INJURY.

  Patient problems: Laceration(s)

  MAUDE report 14675682 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE CAUSED A LACERATION TO FETAL HEAD REQUIRING REPAIR AND POSSIBLY RESULTING IN PERMANENT SCARRING. THE DEVICE WAS IN USE AND PATIENT HAS SKIN INJURY.

  Patient problems: Laceration(s)

  MAUDE report 14653482 ↗
• InjuryMar 28, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THE FSE CAUSED A SMALL SCAB AT BIRTH AND ULTRASOUND REVELED A SMALL PIECE OF THE WIRE WAS RETAINED. NO INFECTION WAS NOTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13932606 ↗
• InjuryMar 27, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO PHILIPS THAT THE BABY DEVELOPED LOCALIZED INFECTION AT FSE SITE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13925171 ↗
• InjuryMar 24, 2022Separation Failure; Separation Failure

  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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13893308 ↗
• InjuryMar 24, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO PHILIPS THAT THE FETAL SPIRAL ELECTRODE CAUSE A SKIN LESION THAT REQUIRED INTERVENTION OF A PLASTIC SURGEON TO MEDICATE THE WOUND.

  Patient problems: Localized Skin Lesion

  MAUDE report 13889250 ↗
• InjuryMar 23, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO PHILIPS THAT THE FETAL SPIRAL ELECTRODE CAUSE A SKIN LESION THAT REQUIRED INTERVENTION OF A PLASTIC SURGEON TO MEDICATE THE WOUND.

  Patient problems: Localized Skin Lesion

  MAUDE report 13861879 ↗
• InjuryMar 21, 2022Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT FETAL SCALP ELECTRODE WAS DIFFICULT TO REMOVE. BEFORE REMOVING FSE, THE METAL PART OF THE ELECTRODE HAD TO REALIGN TO THE NORMAL POSITION CAUSING WOUND ON THE SKIN SURFACE WHICH IS BIT BIGGER THAN NORMAL.

  Patient problems: Abrasion

  MAUDE report 13839822 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO PHILIPS THAT THE SCALP ELECTRODE USED FOR FETAL MONITORING CAUSED A WOUND AND POSSIBLE INFECTION AND SCARS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13822648 ↗
• InjuryMar 4, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED TO PHILIPS THAT HAIR WAS REMOVED FROM THE PATIENT WHEN REMOVING THE ELECTRODE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hair Loss; Insufficient Information

  MAUDE report 13667846 ↗
• InjuryMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO PHILIPS THAT THE FETAL HEART RATE MONITOR SENSOR WAS SO TIGHTLY ATTACHED TO THE BABY'S HEAD THAT IT TOOK 3 PEOPLE TO REMOVE IT. THE DEVICE WAS BEING USED ON A PATIENT THERE WAS A LARGER-THAN-USUAL LEAKING HOLE LEFT IN THE SKIN. A WET SPOT THAT LATER DEVELOPED ON THE SITE, WHICH WAS SQUEEZED EMPTY AND CLEANED WHEN THE BABY WAS (B)(6) AT A PEDIATRIC EXAMINATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13654692 ↗
• InjuryMar 1, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED TO PHILIPS THAT SKIN TISSUE WAS REMOVED THE PATIENT WHEN REMOVING THE ELECTRODE. SKIN TISSUE WAS REMOVED AND THE LESION WAS DISINFECTED AND THE BLEEDING WAS STOPPED.

  Patient problems: Localized Skin Lesion

  MAUDE report 13634646 ↗
• InjuryFeb 9, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO PHILIPS THAT WHEN THE FETAL SCALP ELECTRODE WAS REMOVED, IT WAS NOTICED THAT THE ENTIRE ELECTRODE CAME OFF AND THERE WAS NO METAL SPIRAL AT THE END OF THE ELECTRODE. METAL WAS FOUND LATER FROM BABY¿S HEAD. A CONSULTATION WITH THE SURGEON HAD BEEN PERFORMED AND THE SURGEON HAD THE SPIRAL REMOVED WITHOUT A SEPARATE PROCEDURE.

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 13497731 ↗
• InjuryJan 21, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE DIFFICULT REMOVAL AND CAUSED A SKIN INJURY ON THE BABIES HEAD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13320215 ↗
• InjuryJan 21, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE DIFFICULT REMOVAL AND CAUSED A SKIN INJURY ON THE BABIES HEAD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13319789 ↗
• InjuryJan 21, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE DIFFICULT REMOVAL AND CAUSED A SKIN INJURY ON THE BABIES HEAD. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, THE PATIENT SUFFERED A SKIN INJURY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13315301 ↗
• MalfunctionJan 7, 2022Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE WAS PLACED ONTO THE PATIENT AND WAS NOT ABLE TO REMOVE IT. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, IT WAS REPORTED THE PATIENT HAD SKIN INJURY.

  Patient problems: Abrasion; Needle Stick/Puncture

  MAUDE report 13191561 ↗
• MalfunctionJan 6, 2022Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE WAS PLACED ONTO THE PATIENT AND WAS NOT ABLE TO REMOVE IT. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT AND IT WAS REPORTED THE PATIENT HAD A SKIN INJURY.

  Patient problems: Abrasion; Needle Stick/Puncture

  MAUDE report 13181272 ↗
• MalfunctionJan 6, 2022Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE WAS PLACED ONTO THE PATIENT AND WAS NOT ABLE TO REMOVE IT. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, AND THE PATIENT SUFFERED A SKIN INJURY.

  Patient problems: Abrasion; Needle Stick/Puncture

  MAUDE report 13179260 ↗