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

Model Number 989803137631

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

Serial number not provided.A follow-up report will be submitted once the investigation is complete.We are considering this to be a serious injury,.A request for more information has been made.The customer noted that the product is not available for evaluation.

Event Description

The customer stated that a metal piece was left on the babies scalp.

Manufacturer Narrative

No product will be returned as it was disposed of after it was used.The reported issue was not found and reported until 3 months after the product was used.The customer stated the patient's mother saw the metal piece on the baby¿s scalp and hence informed us and took the baby to the children¿s hospital.The metal piece was removed and the baby was prescribed an antibiotic.The customer has no further information on the baby.The instructions for use (ifu) state to inspect the spiral tip to ensure that it is still attached to the fse hub.If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique.The ifu also states "warning: do not over-rotate".Because the instructions for use include clear directions on how to avoid tip breakage and what to do if it occurs, philips sent a communication to users to remind them of these important directions.No further investigation or action is warranted.

• 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: 8524487
• MDR Text Key: 142277288
• Report Number: 1218950-2019-02812
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• 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,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 287 DA
• Patient Weight: 4