MAUDE manufacturer profile
ZOLL MANUFACTURING CORPORATION · MVK
MAUDE profile for Wearable Automated External Defibrillator
Key facts
| Manufacturer | ZOLL MANUFACTURING CORPORATION |
|---|---|
| Manufacturer group | ZOLL MANUFACTURING CORPORATION |
| Product code | MVK |
| Product code name | Wearable Automated External Defibrillator |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Insufficient Information, Battery Problem, Inappropriate/Inadequate Shock/Stimulation, Failure to Power Up, Device Displays Incorrect Message, Shock from Patient Lead(s) 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