MAUDE Adverse Event Report: BISTOS CO., LTD. FETAL MONITOR/CARDIOTOCOGRAM; TRANSDUCER, ULTRASONIC, OBSTERIC

Model Number BT-350

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 10/16/2017

Event Type  Injury  

Event Description

Fetal monitors/ ctg of manufacturer: bistos co.Ltd., (b)(4) model bt-350 with fda no.K103545 were installed with central monitoring system at (b)(6) hospital (b)(6) on (b)(6) 2017.User department reported of burns at mother site where toco sensors were placed on (b)(6) 2017, the adverse event was reported to manufacturer firm and replacement of toco sensors were made for further prevention of event.On (b)(6) 2018 event of patient burn recurred at the mother site where us and toco sensors were placed, also the user department informed about the arbitrary readings of fhr even without placing the sensor on actual fetus location.The event was reported to manufacturer and no significant resolution had been found till date.Further use of machines had been terminated due to life threatening issues to fetus because of the false readings machines are producing that user would consider as safe readings observing on central monitor even if there had been distress to the fetus.

• Brand Name: FETAL MONITOR/CARDIOTOCOGRAM
• Type of Device: TRANSDUCER, ULTRASONIC, OBSTERIC
• Manufacturer (Section D): BISTOS CO., LTD.
• MDR Report Key: 7227864
• MDR Text Key: 98673318
• Report Number: MW5074953
• Device Sequence Number: 2
• Product Code: HGL
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/26/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BT-350
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other