MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-27 for CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT AH280 manufactured by Vyaire Medical, Inc.
[92996239]
Initial emdr submission: no sample is available. If any additional information becomes available a follow-up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92996240]
Respiratory therapy has changed heated wire circuits for ventilators and the new circuits collect water and occlude the tubing the patient has to breathe through.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00385 |
| MDR Report Key | 7060991 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-27 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2018-02-02 |
| 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 |
| 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 | CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2017-11-27 |
| Catalog Number | AH280 |
| 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 | 26125 N RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-27 |