MAUDE report
MAUDE report 1222: SYSTEM VI
Malfunction · received Aug 27, 1992 · AIR SHIELDS
Key facts
| MDR report key | 1222 |
|---|---|
| Report number | 1222 |
| Event type | Malfunction |
| Brand name | SYSTEM VI |
| Model number | HRS6-1 |
| Manufacturer | AIR SHIELDS |
| Product code | FLS |
| Device class | Class II |
| Date received by FDA | Aug 27, 1992 |
| Report date | Aug 14, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- None Injury reports for this brand
- No Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: