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 2017-11-28 for CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A manufactured by Vyaire Medical, Inc.
[93109645]
Initial emdr submission: sample is available, ups shipping labels provided to customer to have the sample returned. Currently awaiting for the sample. Once the investigation is complete a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[93109646]
We have begun to investigate all our patients with this adapter and o2 with sleep equipment to visually inspect all equipment. We have since found 2 more patients and incidence of melted adapters.
Patient Sequence No: 1, Text Type: D, B5
[109798338]
Sample available. However based on the customer stating the product was in use for 1 year and 5 days, our ifu states this product should not be used longer than 30 days as the product can become deformed or discolored. 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 | 8030673-2017-00389 |
| MDR Report Key | 7064125 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-28 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| Catalog Number | 004081-A |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-28 |