MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-15 for LEVEL 1? HOTLINE? LOW FLOW SYSTEM H-1200 8002950 manufactured by Smiths Medical Asd; Inc..
[179715983]
Information was received indicating that during testing of a smiths medical level 1 trauma fast flow system was overheating after about five minutes of use. Two days following, the unit was noted to not be heating and the reservoir liquid was not circulating. It was reported that the unit was not used on a patient with no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01128 |
| MDR Report Key | 9715087 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-15 |
| Date of Report | 2020-02-15 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2020-02-15 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD; INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? HOTLINE? LOW FLOW SYSTEM |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-02-15 |
| Model Number | H-1200 |
| Catalog Number | 8002950 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-15 |