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

Model Number 989803137631

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Medical device: unable to confirm serial number.Initial reporter: phone not provided.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer claimed that the spiral metal tip dislodged and embedded in newborn's head.The breakage was not noted during labor.It was found during the newborn examination that the metal spiral tip from the fetal spiral electrode was embedded into the newborns scalp, and was removed with minimal trauma.

Manufacturer Narrative

The samples have been returned to the manufacturer for evaluation and we are now awaiting their evaluation results.

Manufacturer Narrative

Requests for more information have been made.The response philips received was that: "the baby was transferred to post natal, and noticed roughly 24 hours later under examination that the tip was still in the back of the babies head and then it was removed with no trauma or injury" and no lot number was available.The fse itself was disposed of post-delivery of the baby as per their normal procedure.The customer did have the broken tip of the fse for available for evaluation.The sample was returned to the manufacturer (clinical innovations) for evaluation and investigation.Clinical innovations evaluation found that the needle was broken at the end where the white plastic needle hub would be.The symptoms of returned device indicate that tip may have broken during the application of the fse due to excess torque force being used.Metallurgic laboratory testing showed no material composition defect and suggested the most likely cause of such a break is the user applying more torque force than is recommended.The customer was sent (b)(4), which was a communication to fse users to remind them to follow the important directions listed in the instructions for use.A philips q&r officer confirmed that the fco went out to the customer in february of 2019.However they never acknowledged receipt, despite the 3 attempts to contact them.Philips has issued clinical innovations a scar to address issues with the fse complaints.(b)(4).

• 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: 8619924
• MDR Text Key: 145398809
• Report Number: 1218950-2019-03552
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019
• Supplement Dates FDA Received: 08/05/2019; 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 DA