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 11/06/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken.The baby required surgery to remove the tip and an overnight stay in the hospital.

Manufacturer Narrative

It was reported that a baby girl/¿patient¿ was born via ¿normal birth¿ and the doctor used the device before the delivery time for monitoring of the fetal heart.Philips was advised that during the birth, the doctor had trouble connecting the device to the infant's head and after repeated attempts, the device had been replaced.At birth, the hospital reportedly saw swelling and redness that they assumed was caused by the repeated attempts to connect the device.Two weeks later, the patient appeared at the emergency room and a metallic foreign body attached to the scalp was noticed.The object was removed by surgery and the patient was hospitalized for one day for observation philips inquired if the difficulty in connecting the device could have resulted in the electrode being over rotated, leading to breakage of the device¿s tip.The distributor responded that the doctor was unaware that the electrode broke, so he likely would not know how it broke.A return material authorization was issued for return of the device involved in the incident for evaluation.However, philips was advised that the hospital team was not aware of the occurrence of the broken electrode.Therefore, the device was not retained.Philips was also informed that the hospital does not have information about the device, batch or any other detail.Further information was requested related to this information, but an answer could not be provided.Philips is considering this a malfunction of cause unknown for reporting purposes only.

• 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: 8270685
• MDR Text Key: 133862798
• Report Number: 1218950-2019-00656
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/20/2019
• Supplement Dates FDA Received: 03/26/2019
• 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 Outcome(s): Other
• Patient Age: 1 DA