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ELECTRODES, ONESTEP COMPLETE, 8-PK, R SERIES Adverse Event — Malfunction (MDR 1218058-2020-00040)

ELECTRODES, ONESTEP COMPLETE, 8-PK, R SERIES Adverse Event — Malfunction (MDR 1218058-2020-00040) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECTRODES, ONESTEP COMPLETE, 8-PK, R SERIES; Generic name: ELECTRODE; Manufacturer: BIO-DETEK INCORPORATED.

DeviceELECTRODES, ONESTEP COMPLETE, 8-PK, R SERIES
Generic nameELECTRODE
ManufacturerBIO-DETEK INCORPORATED
Report number1218058-2020-00040
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceHEALTH PROFESSIONAL
NarrativeZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
SourceopenFDA MAUDE (device adverse events)

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