ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT Adverse Event — Malfunction (MDR 9611451-2020-00425)
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT Adverse Event — Malfunction (MDR 9611451-2020-00425) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; Generic name: BZE; Report number: 9611451-2020-00425.
| Device | ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT |
|---|---|
| Generic name | BZE |
| Report number | 9611451-2020-00425 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | (B)(4). METHOD: THE COMPLAINT RT380 ADULT EVAQUA 2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN (B)(4) AND WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED BREATHING CIRCUIT OR DRYLINE. THE PRESSURE TEST REVEALED THAT THE BREATHING CIRCUIT WAS OUTSIDE THE SPECIFICATION. A WATERBATH TEST SHOWED THAT THE CIRCUIT IS LEA |
| Source | openFDA MAUDE (device adverse events) |
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