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

Model Number (240)138665

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

Micro disposable doppler probe x 2 (same lot#) opened for surgical case but did not function.A third probe was opened and functioned without issue.Biomed verified that the bad probes were non-functional.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; 30057 ahern avenue; union city CA 94587
• MDR Report Key: 10465674
• MDR Text Key: 204988391
• Report Number: MW5096322
• Device Sequence Number: 2
• Product Code: DPW
• Combination Product (y/n): N
• 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: 08/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: (240)138665
• Device Catalogue Number: (240)138665
• Device Lot Number: (10)17002
• 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: 67 YR