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

Model Number 989803137631

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.We are still in the process of assessing the incident.The electrodes were discarded.

Event Description

The customer reported they could not remove the fetal electrode probe from the infant's scalp.Emergent care was provided by the doctor and the tip was removed from the infant's scalp and discarded.

Manufacturer Narrative

The customer reported an intern could not remove the fetal electrode probe from the infant's scalp and that this was the intern's third time having this problem.The attending physician cut the baby's scalp in order to remove the fetal spiral electrode.The fetal spiral assembly was discarded and not available for evaluation.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.It was observed that the intern was applying the electrode with more than one turn and the plastic tip was embossing into the baby¿s scalp.As a result, we are not considering this to be a product malfunction.The ifu for the fse (p/n (b)(4) states in a warning not to over rotate the fse.The date of the incident was not provided.

• 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: 7070368
• MDR Text Key: 93322848
• Report Number: 1218950-2017-08087
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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 Lot Number: 171291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 03/05/2018
• 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 Age: 1 DA