MAUDE Adverse Event Report: CONTEC MEDICAL SYSTEMS CO., LTD SONOLINE B POCKET FETAL DOPPL; MONITOR, ULTRASONIC, FETAL

Model Number	SONOLINE B
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Med watch usa report product: fetal doppler manufacturer: contec medical systems (china) distributor in usa: (b)(4).Issue summary: the fetal doppler device manufactured by contec medical systems in china and distributed in the united states by (b)(4).Is currently subject to a public safety recall in canada by health canada.There are indications that the recall may extend to other jurisdictions as well.Regulatory status and misuse: fda approval: the device is fda-approved for use in hospitals and clinics by medical professionals.Improper marketing: (b)(4) is selling the device for home use in the united states through the website www.Babydoppler.Com, which deviates from its approved intended use.Misleading labeling: the distributor has placed a single disclaimer stating the device is "non-medical." however, this claim is contradictory to the device's actual function of showing unborn baby vitals.Safety concerns: unintended use: marketing a professional medical device for home use by untrained individuals poses significant risks.Misinterpretation of results: non-medical users may misinterpret the device's readings, potentially leading to unnecessary anxiety or false reassurance.Delayed medical care: reliance on this device at home may result in delays in seeking proper medical attention when needed.Lack of professional oversight: without proper medical supervision, users may not receive appropriate guidance on the device's limitations and proper usage.Regulatory implications: violation of fda approval: the distribution and marketing of this device for home use likely violates the terms of its fda approval.Misbranding: the contradictory labeling (claiming non-medical status for a medical device) may constitute misbranding under fda regulations.Consumer safety: the recall in canada suggests potential safety issues that may also affect users in the united states.

• Brand Name: SONOLINE B POCKET FETAL DOPPL
• Common Device Name: MONITOR, ULTRASONIC, FETAL
• Manufacturer (Section D): CONTEC MEDICAL SYSTEMS CO., LTD
• MDR Report Key: 19996203
• Report Number: MW5158483
• Device Sequence Number: 11329005
• Product Code: KNG
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: SONOLINE B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown