MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-27 for CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A manufactured by Vyaire Medical, Inc.
[92998239]
Initial emdr submission: sample is available, (b)(6) shipping labels provided to customer to have the sample returned. Currently waiting for the sample. Once the investigation is complete a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92998240]
The adapters were placed on the resmed vpap auto to the air outlet then to the patient cpap tubing. The u adapters melted at the nipple where the o2 tubing is attached, melted and elongated the plastic and sealed over so no o2 flow could pass through the adapter to the patient. No known injury to patients have been reported.
Patient Sequence No: 1, Text Type: D, B5
[109540733]
No sample, no lot available however based on the customer stating the product was in use for 6 months. Our ifu states this product should not be used for longer than 30 days as the product can become deformed or discolored if used for longer that 30 days. The customer has been provided the ifu and instructed on the proper use of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00386 |
| MDR Report Key | 7061001 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-27 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-11-27 |
| 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 | RESPIRATORY THERAPIST |
| 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 VIA DE LA PRODUCCION NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-11-27 |
| Catalog Number | 004081-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 N RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-27 |