MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-15 for AIRLIFE? HIGH FLOW FIO2 NEBULIZER M37441H manufactured by Vyaire Medical.
[188823596]
The customer reported the product sample and photo is available for analysis. At this time, vyaire has not received the suspect device for evaluation. Any additional information provided by the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188823597]
The customer reported that the airlife high flow fio2 nebulizer's threaded connection fell off and disconnected from the wall. The event occurred while connected to a patient. The customer reported that they had replaced the adapter and placed the patient on a non-re-breathing oxygen mask and confirmed that no patient harm was associated on this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00069 |
| MDR Report Key | 9593752 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-07-22 |
| Date Added to Maude | 2020-01-15 |
| 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 | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| 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? HIGH FLOW FIO2 NEBULIZER |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
| Product Code | CCQ |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2020-02-21 |
| Model Number | AIRLIFE? HIGH FLOW FIO2 NEBULIZER |
| Catalog Number | M37441H |
| Lot Number | 0004105414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |