MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-06 for AIRLIFE? OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED 001302 manufactured by Vyaire Medical..
[188824290]
The customer reported that the sample device is not available for analysis. But the lot number is provided therefore device history review can be obtain. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188824291]
The customer reported that the airlife oxygen tubing is leaking at the same connection site as the green cuff, where the tubing initially meets the cuff site oxygen was leaking profusely. This issue occurred while connected to a patient and the tube was replaced with a new set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00077 |
| MDR Report Key | 9802133 |
| Report Source | OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION85 PARQUE UNDUSTRIAL MEXICALI III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-03-06 |
| Model Number | AIRLIFE? OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT O |
| Catalog Number | 001302 |
| Lot Number | 0004100451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |