MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for LEVEL 1? HOTLINE? BLOOD AND FLUID WARMER HL-90 CON-HL-90 manufactured by Smiths Medical Asd; Inc..
[185901352]
One hotline? Blood and fluid warmer was returned for analysis. The enclosure, front cover, and line cord were observed to be damaged upon visual inspection. The unit was functional tested by filling the tank with water, attached the temp check, plugged in line cord, and turned on power switch; no power noted. Based on the evidence, the complaint was confirmed. The root cause was found due to a faulty pcb.
Patient Sequence No: 1, Text Type: N, H10
[185901353]
Information was received indicating that a smiths medical level 1? Hotline? Blood and fluid warmer would not power on. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02642 |
| MDR Report Key | 9908305 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2018-12-27 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD; INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? HOTLINE? BLOOD AND FLUID WARMER |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2019-10-01 |
| Model Number | HL-90 |
| Catalog Number | CON-HL-90 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |