← DeviceEvents
HomeDevice Adverse Events

V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01574)

V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01574) 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 number2031642-2020-01574
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceUSER FACILITY
NarrativeG4: 11MAY2020 B4: (B)(6)2020. H11: B5: PROBLEM DESCRIPTION: THE CUSTOMER REPORTED THAT THE A BATTERY FAILURE WAS INDICATED AND THE UNIT WILL ALARM, SHOWING NO BATTERY EVEN WHEN THE BATTERY IS CONNECTED. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THAT THE UNIT WOULD ALARM INDICATING NO BATTERY DESPITE THE BATTERY BEING CONNECTED, BUT THE ALARM WOULD TURN OFF AFTER A FEW MINUTES OF OPERATION. SUBMIS
SourceopenFDA MAUDE (device adverse events)

🔍 Search all device adverse events →