MAUDE manufacturer profile
PLEXUS MANUFACTURING SDN. BHD · DTC
MAUDE profile for Analyzer, Pacemaker Generator Function
Key facts
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD |
|---|---|
| Manufacturer group | PLEXUS MANUFACTURING SDN. BHD |
| Product code | DTC |
| Product code name | Analyzer, Pacemaker Generator Function |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Computer Software Problem, Communication or Transmission Problem, Display or Visual Feedback Problem, Computer Operating System Problem, No Consequences Or Impact To Patient, Device Difficult to Program or Calibrate, Device Sensing Problem 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