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HEARTSTART MRX Adverse Event — Malfunction (MDR 1218950-2020-02522)

HEARTSTART MRX Adverse Event — Malfunction (MDR 1218950-2020-02522) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTSTART MRX; Generic name: DEFIBRILLATOR; Manufacturer: PHILIPS MEDICAL SYSTEMS.

DeviceHEARTSTART MRX
Generic nameDEFIBRILLATOR
ManufacturerPHILIPS MEDICAL SYSTEMS
Report number1218950-2020-02522
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceUSER FACILITY
NarrativeIT WAS REPORTED TO PHILIPS THAT THE AC MODULE FOR THE DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
SourceopenFDA MAUDE (device adverse events)

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