MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for HOTLINE BLOOD AND FLUID WARMER HL-390 CON-HL-390 manufactured by Smiths Medical Asd, Inc.
[185479355]
One level 1 hotline low flow system device was returned for analysis. The enclosure and the water tank cover were found dirty and the lcd was visibly damaged. A full inspection was performed, and the reported issue was confirmed. The lcd was found to be damaged. No action was taken due to the age of the device. It's deemed beyond economical repair and will be scrapped.
Patient Sequence No: 1, Text Type: N, H10
[185479356]
Information was received indicating that the smiths hotline blood and fluid warmer displayed a screen that's half black. There were no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02370 |
| MDR Report Key | 9892021 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2020-03-27 |
| 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 NORTH |
| Manufacturer City | MINNEAPLOIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENURE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOTLINE BLOOD AND FLUID WARMER |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2019-09-16 |
| Model Number | HL-390 |
| Catalog Number | CON-HL-390 |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |