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 Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

The 1st two disposable micro dopplers did not work.The 3rd doppler worked without issue.The console had also been evaluated with no issues identified.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
• MDR Report Key: 10619627
• MDR Text Key: 210006560
• Report Number: MW5097037
• 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: 09/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: (240)138665
• Device Lot Number: (10)17128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• 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: 57 YR