MalfunctionDPW
20 MHZ MICRO DISPOSABLE DOPPLER PROBE
Received Oct 1, 2020 · Event occurred Sep 30, 2020
Report MW5097037 · MDR key 10619627
Device
Generic name
Flowmeter, Blood, Cardiovascular
Model number
07-150-12Catalog number
(240)138665
Lot number
(10)17128
Product problems
- Break
Patient
57 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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).