MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-15 for VMAX ENCORE 22 22 E 777404-101 manufactured by Vyaire Medical.
[175172110]
Vyaire file identification: (b)(4). Any additional information received from the customer will be included in a follow-up report. The customer reported the suspected component is available for analysis and was ordered for return. At this time, vyaire has not received the suspected component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[175172111]
The customer reported during installation of a device, the vmax encore 22 e was not functioning. When the customer changed the oxygen (o2) cell, reconnected the vacuum pump, the board started to burn. When the customer installed the same o2 cell on a loaner unit afterwards, the o2 cell was not functional. The customer reported it is unclear if the device burning of the board had anything to do with the o2 cell device not being functional when used. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11283 |
| MDR Report Key | 9593820 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2020-01-15 |
| 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 INC. |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VMAX ENCORE 22 |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2020-01-15 |
| Model Number | 22 E |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-01-15 |