MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for MICROLAB 36-ML3535 MK8-STK 36-ML3500 MK8-STK manufactured by Vyaire Medical.
| Report Number | 9615102-2019-00110 |
| MDR Report Key | 9151983 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-09-26 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2019-10-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | VYAIRE MEDICAL GMBH |
| Manufacturer Street | LEIBNIZSTRASSE 7 |
| Manufacturer City | HOCHBERG, 97204 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 97204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROLAB |
| Generic Name | SPIROMETER, DIAGNOSTIC |
| Product Code | BZG |
| Date Received | 2019-10-03 |
| Model Number | 36-ML3535 MK8-STK |
| Catalog Number | 36-ML3500 MK8-STK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-03 |