MalfunctionDPW
20 MHZ MICRO DISPOSABLE DOPPLER PROBE
Received Aug 27, 2020 · Event occurred Aug 26, 2020
Report MW5096322 · MDR key 10465674
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Mizuho Medical InnovationModel number
(240)138665Catalog number
(240)138665
Lot number
(10)17002
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
67 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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).