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V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01586)

V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01586) 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 number2031642-2020-01586
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceFOREIGN, USER FACILITY
NarrativeG4: 21APR2020 B4: (B)(6)2020. PER TECHNICAL SUPPORT THE UNIT WAS IN USE ON PATIENT, BUT THERE'S NO PATIENT HARM REPORTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
SourceopenFDA MAUDE (device adverse events)

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