MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-09 for LEVEL 1 TRAUMA FAST FLOW SYSTEM H-1200 8002950 manufactured by Smiths Medical Asd, Inc.
[182576413]
Evaluation results: one level 1 trauma fast flow system was returned for investigation in fair condition. The device was manufactured in 2015. The device produced the disposable alarm as soon as it was powered on. The investigator then removed the back cover panel for further investigation. The investigator found that there was a crack in the return tube which had leaked water and damaged multiple components. This confirmed the customer reported product problem. The following components were replaced as a result: return tube, main, and membrane switch. A temp-check test fixture was installed on the device. The measured temperature was 41. 7 degrees which was within tolerance. The device passed all functional and electrical tests. The product problem was attributed to a design issue.
Patient Sequence No: 1, Text Type: N, H10
[182576434]
It was reported that the device had a problem with a switch. The issue was potentially related to the circuit board. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01935 |
| MDR Report Key | 9806377 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-02-03 |
| Date Added to Maude | 2020-03-09 |
| 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 | 3350 GRANADA AVENUE 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 | LEVEL 1 TRAUMA FAST FLOW SYSTEM |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2019-09-27 |
| Model Number | H-1200 |
| Catalog Number | 8002950 |
| 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 | 2020-03-09 |