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 Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Date of event is unknown and has been requested.Serial number not available at time of report.

Event Description

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

Manufacturer Narrative

The product was returned for evaluation.The used electrode spiral tip showed it been stretched out.Microscopic inspection of the material showed no defects in the metal.A quality support engineer also inspected the electrode and concluded the electrode had been pulled rather than rotated to remove it.The instructions for use (ifu) states for the user to ¿turn the grip clockwise, typically one full turn using the protective tab as a visual guide.The ifu warns against over-rotating the spiral tip during attachment and pulling the spiral tip from the fetal skin.We are considering that if the customer required new electrodes, they have purchased some.Philips has not received any confirmation from the consumer about any injury or medical intervention that might have been performed.Without any further information, philips has not been able to determine if this was an adverse event involving injury.

Event Description

The customer reported that the spiral tip of the fetal spiral electrode had had stretched out during the removal of the electrode.

• 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: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7837515
• MDR Text Key: 118910658
• Report Number: 1218950-2018-07056
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 989803137631
• Device Lot Number: 171381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 1 DA