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 2017-10-06 for CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT AH280 manufactured by Vyaire Medical, Inc.
[88445209]
(b)(4). Vyaire has received a representative sample from the same lot number for further evaluation. Vyaire is currently performing an investigation into the reported issue. A follow up mdr will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[88445210]
The customer reported "tons of rain-out observed with heated system. When extubating the patient the vent tubing became dislodged and the water sprayed into my face". Respiratory therapist went to the er for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00371 |
| MDR Report Key | 6921454 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-06 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2018-02-01 |
| Date Added to Maude | 2017-10-06 |
| 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 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 | 3 |
| Brand Name | CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2017-10-06 |
| Returned To Mfg | 2017-09-21 |
| 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 | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-06 |