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

Model Number 989803137631

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Unable to confirm serial number.A follow-up report will be submitted upon completion of the investigation.Additional information has been requested as philips is still in the process of assessing the incident.

Event Description

The customer reported the tip of 989803137631 fetal spiral eletrode broke and remained in the baby's scalp.The tip was discovered by a relative of the baby several hours after birth.It is not known if emergent care was needed.

Manufacturer Narrative

No material was returned for evaluation.The electrode is to be inspected after it has been disengaged for completeness.There is no indication of an increasing or systemic trend; therefore no additional action was deemed warranted.We are considering this complaint to be a product malfunction.It appears that the instructions for use were not followed.It is not known if training was provided to the customer.There has been no response for additional information.

• 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: 7276517
• MDR Text Key: 100258223
• Report Number: 1218950-2018-01849
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 989803137631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA