LEVEL 1 HOTLINE BLOOD AND FLUID WARMER Adverse Event — Malfunction (MDR 3012307300-2020-03454)
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER Adverse Event — Malfunction (MDR 3012307300-2020-03454) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; Generic name: WARMER, THERMAL, INFUSION FLUID; Manufacturer: ST PAUL.
| Device | LEVEL 1 HOTLINE BLOOD AND FLUID WARMER |
|---|---|
| Generic name | WARMER, THERMAL, INFUSION FLUID |
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03454 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | ONE LEVEL 1 HOTLINE BLOOD AND FLUID WARMER WAS RETURNED FOR ANALYSIS WITH A CRACK TO THE TANK COVER. THE UNIT WAS FILLED WITH WATER; CONFIRMING THE COMPLAINT OF LEAKING. BASED ON THE EVIDENCE, THE ROOT CAUSE WAS FOUND TO BE DUE TO USER INTERFACE. |
| Source | openFDA MAUDE (device adverse events) |
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