inforMED
MalfunctionDPW

20 MHZ MICRO DISPOSABLE DOPPLER PROBE

Received Jun 22, 2021 · Event occurred Jun 16, 2021

Report MW5102019 · MDR key 12049465

Device

Generic name

Flowmeter, Blood, Cardiovascular

Model number

07-150-12

Catalog number

07-150-12

Lot number

(10)17128

Product problems

  • Output Problem

Patient

39 YR

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

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).