VAPOTHERM Adverse Event — Malfunction (MDR 10000396)
VAPOTHERM Adverse Event — Malfunction (MDR 10000396) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VAPOTHERM; Generic name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); Manufacturer: VAPOTHERM, INC..
| Device | VAPOTHERM |
|---|---|
| Generic name | HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) |
| Manufacturer | VAPOTHERM, INC. |
| Report number | 10000396 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | BABY'S SPO2 KEPT DROPPING ON THE MONITOR. WHEN GOING TO ASSESS BABY, BABY WAS CALM AND BREATHING FAST. VAPOTHERM KEPT SHOWING THAT THERE WAS A KINK IN THE CIRCUIT. WHEN RESPIRATORY THERAPIST WENT TO GO ASSESS THE TUBE FROM PATIENT TO MACHINE THERE WAS NO KINK. THIS DEVICE HAS BEEN RETIRED, IT WAS USED AS A TRADE-IN FOR A NEW DEVICE. |
| Source | openFDA MAUDE (device adverse events) |
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