ESPRIT VENTILATOR Adverse Event — Malfunction (MDR 2031642-2008-00046)
ESPRIT VENTILATOR Adverse Event — Malfunction (MDR 2031642-2008-00046) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ESPRIT VENTILATOR; Generic name: VENTILATOR, CONTINUOUS; Manufacturer: RESPIRONICS CALIFORNIA, INC..
| Device | ESPRIT VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS |
| Manufacturer | RESPIRONICS CALIFORNIA, INC. |
| Report number | 2031642-2008-00046 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Health Professional |
| Narrative | THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SHUT DOWN WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A 24/12 VOLT FAILURE. DURING TESTING THE VENTILATOR WOULD ONLY OPERATE FOR |
| Source | openFDA MAUDE (device adverse events) |
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