SONOLINE B HEARTBEAT MONITOR B073WKDT2H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for SONOLINE B HEARTBEAT MONITOR B073WKDT2H manufactured by Contec Medical Systems Co., Ltd..

Event Text Entries

[106457139] My wife and i are expecting our first baby. We were on amazon looking for a baby registry idea and we came across this product which promotes that you can hear your baby heartbeat at home whenever you like. The idea was fun so after reading all the reviews on amazon, we purchased it and got it in two days. The product came along with an ultrasound gel which we used it. We tried for 20-30 mins to spot the heartbeat with no luck. At this stage we were absolutely shaking to our bones as we thought we might have lost our baby (since we had baby loss before). We rushed to the clinic for a dr visit. She told us baby is ok and she strongly advised against the use of this device as it has radiation. We came home and started researching online and to our surprise we found that this device is not supposed to be used by people at home, is a medical device required to be operated with licensed professionals. The price could potentially harm unborn babies is overused and also can cause birth defect (including hearing impairment. ) we contacted amazon customer support with the hope that other people will not go through the same trauma but seems that amazon staff are just handling general inquires. This link is from fda site warning on that https://www. Fda. Gov/forconsumers/consumerupdates/ucm095508. Htm 10 reason against the use at home https://www. Mamanatural. Com/fetal-heart-monitor-10-reasons-to-stay-away.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5076723
• MDR Report Key: 7458943
• Date Received: 2018-04-25
• Date of Report: 2018-04-05
• Date of Event: 2018-04-03
• Date Added to Maude: 2018-04-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• 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: 3

Device Details

• Brand Name: SONOLINE B HEARTBEAT MONITOR
• Generic Name: MONITOR, ULTRASONIC, FETAL
• Product Code: KNG
• Date Received: 2018-04-25
• Model Number: B073WKDT2H
• Catalog Number: B073WKDT2H
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONTEC MEDICAL SYSTEMS CO., LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-04-25