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

Model Number 989803137631

Device Problem Material Fragmentation (1261)

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

Event Date 05/18/2021

Event Type  Injury  

Event Description

The customer reported that fse went missing and was found on the newborn's head.The customer also stated there was no abnormality in the newborn patient after removal of the needle.

Manufacturer Narrative

The device was returned and evaluated by the supplier.The compliant was confirmed, upon receipt of the device the needle was found to be broken apart from he electrode hub.The failure was determined to be most likely due to user error the failure was determined to be most likely due to user error.The customer was provided information and the device was scrapped.No further actions were taken and none are warranted.

Event Description

The customer reported that fse went missing and was found on the newborn's head.The customer also stated there was no abnormality in the newborn patient after removal of the needle.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11900494
• MDR Text Key: 253132777
• Report Number: 1218950-2021-10607
• 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,user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 192600
• Distributor Facility Aware Date: 05/18/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other