RENASYS TOUCH DEVICE & POWER SUP Adverse Event — Malfunction (MDR 8043484-2020-00333)
RENASYS TOUCH DEVICE & POWER SUP Adverse Event — Malfunction (MDR 8043484-2020-00333) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RENASYS TOUCH DEVICE & POWER SUP; Generic name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP; Manufacturer: SMITH & NEPHEW MEDICAL LTD..
| Device | RENASYS TOUCH DEVICE & POWER SUP |
|---|---|
| Generic name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Report number | 8043484-2020-00333 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE DEVICE INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION, ESTABLISHING NO RELATIONSHIP BETWEEN THE EVENT REPORTED. A VISUAL AND FUNCTIONAL EVALUATION FOUND NO FAULTS. ALARM THRESHOLDS ARE SET AFTER THOROUGH TESTING AND ARE ALWAYS SET TO ENSURE THE COMPLETE SAFETY OF THE PATIENT. IT IS POSSIBLE IN EXTREME CASES THAT THE ALARM MAY TRIGGER INADVERTENTLY. IN THIS INSTANCE THERAPY WILL STIL |
| Source | openFDA MAUDE (device adverse events) |
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