LEVEL 1 Adverse Event — Malfunction (MDR 3012307300-2020-03396)
LEVEL 1 Adverse Event — Malfunction (MDR 3012307300-2020-03396) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEVEL 1; Generic name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION; Manufacturer: ST PAUL.
| Device | LEVEL 1 |
|---|---|
| Generic name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03396 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF A SMITHS MEDICAL LEVEL 1 H-1200 FAST FLOW FLUID WARMER LED LIGHTS WERE LIGHTING UP RED. IT WAS ALSO REPORTED THAT THE POWER SWITCH WAS OBSERVED TO BE GOING ON AND OFF MAKING IT DIFFICULT TO POWER UP. THERE WAS NO PATIENT INVOLVEMENT WITH NO REPORTED ADVERSE EFFECTS. |
| Source | openFDA MAUDE (device adverse events) |
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