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AIRLIFE MISTY-NEB MEDICATION NEBULIZERS Adverse Event — Malfunction (MDR 8030673-2020-00095)

AIRLIFE MISTY-NEB MEDICATION NEBULIZERS Adverse Event — Malfunction (MDR 8030673-2020-00095) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AIRLIFE MISTY-NEB MEDICATION NEBULIZERS; Generic name: NEBULIZING SYSTEM, NON-HEATED; Manufacturer: VYAIRE MEDICAL.

DeviceAIRLIFE MISTY-NEB MEDICATION NEBULIZERS
Generic nameNEBULIZING SYSTEM, NON-HEATED
ManufacturerVYAIRE MEDICAL
Report number8030673-2020-00095
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, USER FACILITY
NarrativeRESULT OF INVESTIGATION: REVIEW OF DEVICE HISTORY RECORD OF THE LOT NUMBER REVEALED NO ANOMALIES, AND A SAMPLE HAD BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. UNFORTUNATELY, THAT SAMPLE WAS DISCARDED BY MISTAKE. HOWEVER, TECHNICAL TEAM INDICATED THAT CAPA-000000567 HAS BEEN INITIATED BASED ON A SIMILAR PROBLEM, AND THE MANUFACTURING DATE OF THE PRODUCT REPORTED ON THIS COMPLAINT IS COVERED B
SourceopenFDA MAUDE (device adverse events)

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