MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-26 for OXYCON PRO 143900 manufactured by Vyaire Medical.
[143372866]
The suspect device is not available to be returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[143372867]
The customer reported the loud noise and a burning smell coming from the oxycon pro system under the ventilated hood part. The fan component is not moving freely and catching on edges. The customer has requested a warranty replacement for the defective device and the vyaire technical support specialist has processed the order for a new replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615102-2019-00104 |
| MDR Report Key | 8558284 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-26 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2019-04-26 |
| 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 | LEIBENIZSTRASSE 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 | OXYCON PRO |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2019-04-26 |
| Catalog Number | 143900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-04-26 |