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

Model Number BT-350

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Burn, Thermal (2530)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Fetal monitors/cardiotocogram machines of manufacturer: bistos co., ltd model bt-350 with fda no.(b)(4) were installed with central monitoring system at (b)(6) hospital (b)(6) on (b)(6) 2017.User reported of burns at mother site where toco sensors were placed on (b)(6) 2017.The event was reported to manufacturer and few toco sensors were replaced.On (b)(6) 2018 more events of burns were reported with us and toco sensors, also the user reported for false readings of fhr in machines even without placing the us sensor at actual fetus location.Manufacturer was reported of these events and no resolution is made till date.Further use of machines is suspended due to life threatening issues concerned with fetus because machines are giving false readings that may be considered as actual observing on central monitor and could not alert the user department for any distress or emergency situation of fetus that may lead to uterine death.

• Brand Name: FETAL MONITOR
• Type of Device: TRANSDUCER, ULTRASONIC, OBSTERIC
• Manufacturer (Section D): BISTOS CO., LTD.
• MDR Report Key: 7227791
• MDR Text Key: 98663953
• Report Number: MW5074946
• 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: Other Health Care Professional
• 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?: Yes
• 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