AESTIVA MRI Adverse Event — Malfunction (MDR 2112667-2020-01350)
AESTIVA MRI Adverse Event — Malfunction (MDR 2112667-2020-01350) 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 | 2112667-2020-01350 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE SENSOR INTERFACE BOARD (SIB) WAS RECOMMENDED FOR REPLACEMENT TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. |
| Source | openFDA MAUDE (device adverse events) |
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