MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for TUBING ASSEMBLY INFANT RESP O2 30/CS 5550-504 manufactured by Vyaire Medical..
[188823890]
The sample was not returned for evaluation. Therefore the defect reported by the customer cannot be confirmed and no root cause could be determined. Any additional information received from the customer will be included in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[188823891]
The customer reported that the tubing assembly infant respiratory care does not fit in the fisher & paykel infant optiflow circuit. The customer confirmed that there was a delay in patient care but it did not result in patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00086 |
| MDR Report Key | 9771556 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-10-25 |
| Device Manufacturer Date | 2019-06-26 |
| Date Added to Maude | 2020-02-28 |
| 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 | 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 #85, PARQUE UNDUSTRIAL MEX 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 | TUBING ASSEMBLY INFANT RESP O2 30/CS |
| Generic Name | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER |
| Product Code | BZE |
| Date Received | 2020-02-28 |
| Model Number | TUBING ASSEMBLY INFANT RESP O2 30/CS |
| Catalog Number | 5550-504 |
| Lot Number | 0004102069, 0004104917 |
| 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. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |