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V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01579)

V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01579) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: V60 VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY; Manufacturer: RESPIRONICS CALIFORNIA, INC.

DeviceV60 VENTILATOR
Generic nameVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY
ManufacturerRESPIRONICS CALIFORNIA, INC
Report number2031642-2020-01579
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceUSER FACILITY
NarrativeG4: 27MAY2020. B4: 27MAY2020. THE USER INTERFACE ASSEMBLY WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. AN INVESTIGATION WAS PERFORMED, AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT THE ROOT CAUSE WAS ISOLATED TO THE LIQUID CRYSTAL DISPLAY (LCD). SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERS
SourceopenFDA MAUDE (device adverse events)

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