ENGSTROM Adverse Event — Malfunction (MDR 2112667-2020-01353)
ENGSTROM Adverse Event — Malfunction (MDR 2112667-2020-01353) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENGSTROM; Generic name: CRITICAL CARE VENTILATER; Manufacturer: DATEX-OHMEDA, INC..
| Device | ENGSTROM |
|---|---|
| Generic name | CRITICAL CARE VENTILATER |
| Manufacturer | DATEX-OHMEDA, INC. |
| Report number | 2112667-2020-01353 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE BATTERIES AND CABLE WILL BE REPLACED BY THE CUSTOMER TO RESOLVE THE REPORTED EVENT. |
| Source | openFDA MAUDE (device adverse events) |
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