LEVEL 1 HOTLINE FLUID WARMING ACCESSORY Adverse Event — Malfunction (MDR 3012307300-2020-03434)
LEVEL 1 HOTLINE FLUID WARMING ACCESSORY Adverse Event — Malfunction (MDR 3012307300-2020-03434) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEVEL 1 HOTLINE FLUID WARMING ACCESSORY; Generic name: WARMER, THERMAL, INFUSION FLUID; Manufacturer: ST PAUL.
| Device | LEVEL 1 HOTLINE FLUID WARMING ACCESSORY |
|---|---|
| Generic name | WARMER, THERMAL, INFUSION FLUID |
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03434 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | EVALUATION RESULTS: ONE HL-90 115V ELECTRONIC ASSEMBLY (LEVEL 1 HOTLINE FLUID WARMING ACCESSORY) WAS RETURNED FOR INVESTIGATION IN USED CONDITION. VISUAL INSPECTION REVEALED THAT PCB BOARD WAS IN GOOD CONDITION. THE INVESTIGATOR FIRST INSTALLED THE PCB BOARD TO A TEST UNIT. THE INVESTIGATOR THEN FILLED THE TANK WITH WATER, PLUGGED IN THE LINE CORD, AND TURNED ON THE POWER SWITCH. THE CUSTOMER REPO |
| Source | openFDA MAUDE (device adverse events) |
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