AESTIVA MRI Adverse Event — Malfunction (MDR 2112667-2020-01358)
AESTIVA MRI Adverse Event — Malfunction (MDR 2112667-2020-01358) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AESTIVA MRI; Generic name: ANESTHESIA GAS MACHINE; Manufacturer: DATEX-OHMEDA, INC..
| Device | AESTIVA MRI |
|---|---|
| Generic name | ANESTHESIA GAS MACHINE |
| Manufacturer | DATEX-OHMEDA, INC. |
| Report number | 2112667-2020-01358 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE SENSOR INTERFACE BOARD (SIB) WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. UDI# (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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