MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE SINGLE

Model Number 989803137631

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Fse was applied and staff reported lots of artifact.A new fse was applied with artifact continuing to be a problem.4 different fse's were applied with no improvement.Artifact continued to be present to the point that it was difficult to monitor fhr.Staff were not able to improve signal acquisition.The fse did not perform as expected.These are very experienced users.The device was being used according to instructions.The device was in clinical use at the time.There was a delay in delivery of care due to the failure of fses tried.The fse was being used with m2703a fm30 and 989803137651 (reusable decg legplate adapter cable) fse lot number: 193643 this hospital had a second box of electrodes with a different lot number.I instructed them to remove lot number 193643 from clinical use and use the second box.At the time of reporting this, i have not received feedback if the same problem persisted with the second lot.Potential safety impact: this resulted in a delay in patient care.No harm to mother or baby at the time of writing this report.

Event Description

The customer reported that reported fse (fetal spiral electrode) was applied and had lots of artifacts.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A good faith effort was made to get part back for evaluation associated with this complaint evaluation, but there is no additional information available as the reported part was scrapped by the customer.Based on investigation, there is insufficient data available to determine the actual cause of the incident.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE SINGLE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11597176
• MDR Text Key: 243423376
• Report Number: 1218950-2021-10250
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• 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,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 193643
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1