SERVO-S Adverse Event — Malfunction (MDR 8010042-2020-00249)
SERVO-S Adverse Event — Malfunction (MDR 8010042-2020-00249) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SERVO-S; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: MAQUET CRITICAL CARE AB.
| Device | SERVO-S |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Report number | 8010042-2020-00249 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | OUR FIELD SERVICE ENGINEER INVESTIGATED THE REPORTED VENTILATOR UNIT AT THE HOSPITAL, AND FOUND AN EXCESSIVE AMOUNT OF MOISTURE IN THE AIR GAS MODULE. THE AIR GAS MODULE WAS REPLACED. NO GOODS HAS BEEN RECEIVED FOR INVESTIGATION. THE FAILURE WAS CAUSED BY THE LARGE AMOUNT OF MOISTER INSIDE THE AIR GAS MODULE. THE MOISTER HAS PROBABLY AFFECTED THE DELTA PRESSURE TRANSDUCER ON A PRINTED CIRCUIT BOAR |
| Source | openFDA MAUDE (device adverse events) |
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