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

Model Number 989803137631

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

Serial number unknown.

Event Description

The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken and a part is in the back of a child's head.

Manufacturer Narrative

An evaluation could not be completed due to the material in question was discarded at the customer site.The customer was not aware the fetal spiral electrode (fse) tip had broken off and disposed of the fse without checking the tip.Capa (b)(4) was opened to investigate the fetal spiral electrode tips breaking off as well as (b)(4), clinical assessment (b)(4) and regulatory compliance evaluation (b)(4).The instructions for use directs the user how to remove the fse and inspect the tip for any breakage.Philips sent a communication to users to remind them of these important directions.No further investigation or action is warranted.An evaluation could not be completed due to the material in question was discarded at the customer site.

• 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: 8683110
• MDR Text Key: 147495685
• Report Number: 1218950-2019-04082
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 1 DA