FETAL MONITOR/CARDIOTOCOGRAM BT-350

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for FETAL MONITOR/CARDIOTOCOGRAM BT-350 manufactured by Bistos Co., Ltd..

Event Text Entries

[98673318] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5074953
• MDR Report Key: 7227864
• Date Received: 2018-01-29
• Date of Report: 2018-01-26
• Date of Event: 2017-10-16
• Date Added to Maude: 2018-01-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FETAL MONITOR/CARDIOTOCOGRAM
• Generic Name: TRANSDUCER, ULTRASONIC, OBSTERIC
• Product Code: HGL
• Date Received: 2018-01-29
• Model Number: BT-350
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BISTOS CO., LTD.

Device Sequence Number: 2

• Brand Name: FETAL MONITOR/CARDIOTOCOGRAM
• Generic Name: TRANSDUCER, ULTRASONIC, OBSTERIC
• Product Code: HGL
• Date Received: 2018-01-29
• Model Number: BT-350
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BISTOS CO., LTD.

Device Sequence Number: 3

• Brand Name: FETAL MONITOR/CARDIOTOCOGRAM
• Generic Name: TRANSDUCER, ULTRASONIC, OBSTERIC
• Product Code: HGL
• Date Received: 2018-01-29
• Model Number: BT-350
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: BISTOS CO., LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2018-01-29