MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C 004204-A manufactured by Vyaire Medical, Inc.
[77212893]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77212894]
The customer reported that? The oxygen port on this connector seems to have? Melted? According to the facility, causing the oxygen concentrator unable to maintain liter flow?. The patient did not change the adaptor in over one year. Once replaced with new adaptor, liter flow improved. "the patient felt like she could not breathe and thought something was wrong with the concentrator when she noticed the ball to increase liter flow would not rise at all staying below 1 liter?. The customer reported that the patient was not told to change the connector every 30 days. The customer reported that did not know this at the time, and now have seen this written on the package. The patient? Did not have any respiratory comprise at all".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00341 |
| MDR Report Key | 6624645 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-06-08 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-06-08 |
| Catalog Number | 004204-A |
| Lot Number | 0000991207 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-08 |