MalfunctionDRL
FLUKE BIOMEDICAL
Received Jul 8, 2026 · Event occurred Jun 8, 2026
Report 0002921581-2026-00001 · MDR key 25751488
Device
Generic name
Impulse 6000d, Impulse 7000dp
Manufacturer
Fluke BiomedicalModel number
IMPULSE 6000D, IMPULSE 7000DPCatalog number
2811928, 2811919
Lot number
VARIOUS
Product problems
- Application Program Problem: Parameter Calculation Error
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Relabeling
- Modification/Adjustment
- Notification