MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-07-31 for JAEGER V-175420 175452-13 manufactured by Vyaire Medical.
Report Number | 9615102-2019-00107 |
MDR Report Key | 8847823 |
Report Source | FOREIGN,USER FACILITY |
Date Received | 2019-07-31 |
Date of Report | 2019-07-01 |
Date of Event | 2019-07-01 |
Date Mfgr Received | 2019-07-01 |
Date Added to Maude | 2019-07-31 |
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 | 510 TECHNOLOGY DRIVE |
Manufacturer City | IRVINE CA 92618 |
Manufacturer Country | US |
Manufacturer Postal | 92618 |
Manufacturer Phone | 7149193324 |
Manufacturer G1 | VYAIRE MEDICAL GMBH |
Manufacturer Street | LEIBNIZSTRASSE 7 |
Manufacturer City | HOECHBERG, 97204 |
Manufacturer Country | GM |
Manufacturer Postal Code | 97204 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | JAEGER |
Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
Product Code | BZC |
Date Received | 2019-07-31 |
Model Number | V-175420 |
Catalog Number | 175452-13 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
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 | 1. Other | 2019-07-31 |