MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS; CABLE, ELECTRODE

Model Number VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  Death  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.

Event Description

The customer reported that all things were well with the fetus during monitoring with the vital signs" fetal spiral electrode cable for corometrics, round connector, 2.4.Score looked normal.However, after delivery, it was found out that the fetus died a time ago.It is unknown where the signal came from during measurement.

• Brand Name: VITAL SIGNS FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park,; dengwu village, qiaotou town; dongguan, 52353 3; CH 523533
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11485074
• MDR Text Key: 239791111
• Report Number: 3013596024-2021-00001
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993751
• 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
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4
• Device Catalogue Number: 1590AAO
• Device Lot Number: S04201-H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death