WOMB MUSIC HEARTBEAT MONITOR

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 WOMB MUSIC HEARTBEAT MONITOR manufactured by Shenzhen Jumper Medical Equipment Co., Ltd..

Event Text Entries

[106829767] I recently purchased the womb music heartbeat baby monitor from (b)(6) and at the first attempt of usage something seemed like it short circuited and shocked my belly really hard. I was in intense pain right away. It was almost like a shock with a burning sensation. I didn't know this at first but as soon as i reported this to my family dr, she told me about these fetal dopplers and that they shouldn't been used without a medical professional's supervision. At this point i couldn't help to think about the safety and health of my baby. I was really worried that the shock could have harmed my baby. But i will not know this until my baby is born. I was curious at first when i purchased this item thinking whether it would need a prescription or not. Only after i used it i realized that it was a prescription medical device that was actually manufactured by (b)(4). My dr strongly advised not to use it and make sure to never buy something like this from (b)(6). I was really worried and disappointed at the same time to realize that something like this was readily available for me to purchase.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5076756
• MDR Report Key: 7464217
• Date Received: 2018-04-25
• Date of Report: 2018-04-24
• Date of Event: 2018-04-19
• Date Added to Maude: 2018-04-26
• 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: PATIENT
• 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 Details

• Brand Name: WOMB MUSIC HEARTBEAT MONITOR
• Generic Name: MONITOR, ULTRASONIC, FETAL - FETAL DOPPLER
• Product Code: KNG
• Date Received: 2018-04-25
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2018-04-25