MAUDE manufacturer profile
HEARTSINE TECHNOLOGIES LTD · MKJ
MAUDE profile for Automated External Defibrillators (Non-Wearable)
Key facts
| Manufacturer | HEARTSINE TECHNOLOGIES LTD |
|---|---|
| Manufacturer group | HEARTSINE TECHNOLOGIES LTD |
| Product code | MKJ |
| Product code name | Automated External Defibrillators (Non-Wearable) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Self-Activation or Keying, Device Operates Differently Than Expected, No Clinical Signs, Symptoms or Conditions, Defective Device, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Failure to Power Up Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1