MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-24 for JAEGER 001-175452 manufactured by Vyaire Medical.
[143038184]
Vyaire file identification: (b)(4). Any additional information received from the customer will be included in a follow-up report. A vyaire technical support initiated a warranty exchange in which the burnt-smelling module was received. The burnt module was received and was warranted for an exchange for a replacement module to be sent to the customer to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[143038185]
The customer reported while using the calculator, pulmonary function data master screen device; the customer noted a burnt smell when the flap control unit was not functioning. The customer reported there was no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615102-2019-00103 |
| MDR Report Key | 8547170 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2011-03-31 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | CAREFUSION GERMANY 234 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 | JAEGER |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2019-04-24 |
| Model Number | JAEGER |
| Catalog Number | 001-175452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-24 |