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HEARTSTART ONSITE Adverse Event — Malfunction (MDR 3030677-2020-00717)

HEARTSTART ONSITE Adverse Event — Malfunction (MDR 3030677-2020-00717) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTSTART ONSITE; Generic name: AED; Manufacturer: PHILIPS MEDICAL SYSTEMS.

DeviceHEARTSTART ONSITE
Generic nameAED
ManufacturerPHILIPS MEDICAL SYSTEMS
Report number3030677-2020-00717
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceDISTRIBUTOR, FOREIGN
NarrativeIT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
SourceopenFDA MAUDE (device adverse events)

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