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

Model Number 989803137631

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.The electrode was disposed of by the customer.

Event Description

The customer reported that the spiral tip of the fetal spiral electrode ((b)(4)) had broken.The tip of the electrode was removed from the baby's scalp.

Manufacturer Narrative

The customer reported the tip of 989803137631 fetal spiral electrode broke and remained in the baby's scalp.During the cesarean birth, the fetal spiral electrode could not be removed, so the wires were cut.After the birth, the remaining tip of the fetal spiral electrode was removed.A product return was requested, but no product was returned for evaluation.Therefore, the reported problem could not be confirmed.It is possible that the electrode was over-rotated, but this cannot be confirmed due to no product return.A refresher training session has been offered to the hospital staff.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7743589
• MDR Text Key: 115828084
• Report Number: 1218950-2018-06153
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 989803137631
• Device Lot Number: 180524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA