MAUDE Adverse Event Report: MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED 20 MHZ MICRO DISPOSABLE DOPPLER PROBE; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number 07-150-12

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

A 20 mhz micro disposable doppler probe did not work.Replaced with "like" device from another lot which functioned without issue.Fda safety report id# (b)(4).

• Brand Name: 20 MHZ MICRO DISPOSABLE DOPPLER PROBE
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED; nashua NH 03062
• MDR Report Key: 12049465
• MDR Text Key: 258052948
• Report Number: MW5102019
• Device Sequence Number: 1
• Product Code: DPW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 07-150-12
• Device Catalogue Number: 07-150-12
• Device Lot Number: (10)17128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR