MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-05 for MASK 3-IN-1 HI-CONC O2 ADULT W/7FT O2 001210 manufactured by Vyaire Medical.
[126155755]
(b)(4). Any additional information provided by the customer will be included in a follow up report. At this time, vyaire has not received the suspect device/component for evaluation. Due to device unavailability, no further evaluation can be completed a this time.
Patient Sequence No: 1, Text Type: N, H10
[126155756]
It was reported to vyaire that the oxygen reservoir bag did not inflate properly. The customer reported potential patient harm associated with the reported issue. The patient "desated" and was unable to complete his regular 6 minute walk. The reported malfunction caused the patients saturation to drop to 61%. No further harm was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00016 |
| MDR Report Key | 8038503 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-05 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-11-05 |
| 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 | MRS. 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 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V 85 PARQUE UNDUSTRIAL MEX 3 |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASK 3-IN-1 HI-CONC O2 ADULT W/7FT O2 |
| Generic Name | ADULT OXYGEN MASK |
| Product Code | KGB |
| Date Received | 2018-11-05 |
| Returned To Mfg | 2018-12-05 |
| Catalog Number | 001210 |
| Lot Number | 0004034820 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2018-11-05 |