MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-03 for LEVEL 1 TRAUMA FAST FLOW SYSTEM H1200 8002950 manufactured by Smiths Medical Asd, Inc.
[181924411]
Evaluation results: one level 1 trauma fast flow system with a h-2 pressure cuff was received in fair condition. The device was manufactured in 2007. Visual inspection revealed that the h-31b air detector optical key sensor assembly was broken due to customer damage. The customer reported product problem was therefore confirmed. The h-31 optical key sensor assembly and mount block assembly were replaced as a result. A tempcheck test fixture was fitted on the device. The measured temperature was 41. 7 degrees which was within tolerance. The unit passed all functional and electrical tests.
Patient Sequence No: 1, Text Type: N, H10
[181924412]
It was reported that the air detector key sensor was broken. The product problem was observed during preventative maintenance. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01636 |
| MDR Report Key | 9782476 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2007-05-31 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2019-07-30 |
| Model Number | H1200 |
| 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 | 2020-03-03 |