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RENASYS TOUCH NON CONNECT 4TH ED DEVICE Adverse Event — Malfunction (MDR 8043484-2020-00334)

RENASYS TOUCH NON CONNECT 4TH ED DEVICE Adverse Event — Malfunction (MDR 8043484-2020-00334) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RENASYS TOUCH NON CONNECT 4TH ED DEVICE; Generic name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP; Manufacturer: SMITH & NEPHEW

DeviceRENASYS TOUCH NON CONNECT 4TH ED DEVICE
Generic nameNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Report number8043484-2020-00334
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeIT WAS REPORTED THAT THE RENASYS DEVICE WAS ALARMING CANISTER FULL WHEN THERE IS NOTHING IN THE 300ML CANISTER BOTH DEVICE AND CANISTER REPLACED HOWEVER ALARM CONTINUED. THERAPY WAS CONTINUED WITH A BACKUP DEVICE. NO PATIENT HARM REPORTED.
SourceopenFDA MAUDE (device adverse events)

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