MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for LEVEL 1 HOTLINE BLOOD AND FLUID WARMER HL-90-INT-230? manufactured by Smiths Medical Asd, Inc..
[184999159]
Foreign report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184999160]
Information was received that a smiths medical level 1 hotline blood and fluid warmer he device is not heating the water. Sometimes yes, but most of the time it does not. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02181 |
| MDR Report Key | 9881831 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-03-26 |
| 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 | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| 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 |
| Product Code | LGZ |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-12 |
| Catalog Number | HL-90-INT-230? |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-26 |