MalfunctionEMN
JACK SCALER
Received Feb 3, 2020 · Event occurred Jan 30, 2020
Report MW5092728 · MDR key 9665595
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CATASTROPHIC INSTRUMENT FAILURE OF APPROXIMATELY 20-30 INSTRUMENTS, PURCHASED SINCE 2018. FDA SAFETY REPORT ID # (B)(4).