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 No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

It is unknown if emergent care/treatment was necessary.Therefore, this is being considered as a serious injury.At this time, there is indication of user error since the crnas were instructed that they were using the wrong extension.As a result, we are considering this to be reportable at this time.A follow up report will be submitted once the investigation is complete.¿.

Event Description

The customer reported they could not get a clear trace and, as a result, turned the 989803137631 fetal spiral electrode (fse) to obtain the clear trace.The customer reported that they ultimately overturned the fse which resulted in the tip of the fse breaking off into the infant¿s scalp.The broken tip was not discovered after delivery and, a week later, the tip was discovered in 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 they could not get a clear trace and, as a result, turned the (b)(4) fetal spiral electrode (fse) to obtain the clear trace.The customer reported that they ultimately overturned the fse, which resulted in the tip of the fse breaking off into the infant¿s scalp.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.We are not considering this to be a product malfunction, since the user reported that they overturned the device.The ifu for the fse (b)(4) states in a warning not to over rotate the fse.Return material authorization was provided to the customer for return of the (b)(4) fse that was in use during the reported incident for evaluation.However, it was reported that the customer had discarded the fse assembly and the fragment was not available for evaluation.The customer did return unused product from the same lot code.The returned electrodes were inspected under magnification with a microscope.There were no defects noted with he returned material.

• 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: 6756781
• MDR Text Key: 81494693
• Report Number: 1218950-2017-05140
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 989803137631
• Device Lot Number: 170518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA