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HEART START XL Adverse Event — Malfunction (MDR 1218950-2020-02505)

HEART START XL Adverse Event — Malfunction (MDR 1218950-2020-02505) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEART START XL; Generic name: DEFIBRILLATOR; Manufacturer: PHILIPS MEDICAL SYSTEMS.

DeviceHEART START XL
Generic nameDEFIBRILLATOR
ManufacturerPHILIPS MEDICAL SYSTEMS
Report number1218950-2020-02505
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, USER FACILITY
NarrativeIT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED A SYSTEM CHECK. THERE WAS NO PATIENT INVOLVEMENT.
SourceopenFDA MAUDE (device adverse events)

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