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PHOENIX Adverse Event — Other (MDR 2087532-2008-00006)

PHOENIX Adverse Event — Other (MDR 2087532-2008-00006) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PHOENIX; Generic name: HEMODIALYSIS EQUIPMENT; Manufacturer: GAMBRO DASCO.

DevicePHOENIX
Generic nameHEMODIALYSIS EQUIPMENT
ManufacturerGAMBRO DASCO
Report number2087532-2008-00006
Event typeOther
Product problemY
Date received2008-01-22
NarrativeGAMBRO REC'D A COMPLAINT ON DECEMBER 23RD, 2007 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING. IT WAS UNK WHEN THE LEAK OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION WARRANTED IN THIS EVENT. NO EVIDENCE THAT AN ALARM OCCURRED. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THAT THERE WERE SEVERAL POWER OUTAGES AND THE CONNECTOR CAME OFF OF THE BOTTOM OF THE EV2 VALVE. T
SourceopenFDA MAUDE (device adverse events)

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