MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-11 for LEVEL 1 TRAUMA FAST FLOW SYSTEM H-1200 8002950 manufactured by Smiths Medical Asd, Inc.
[183086329]
Evaluation results: one level 1 trauma fast flow system was returned for investigation in fair condition. The investigator set the air regulator pressure to 5. 6 psi +0/-2psi. The h-2 pressure gauge read below the expected 270-300 mmgh. The customer reported product problem was therefore confirmed. The pressure gauges were replaced as a result. The unit passed all functional tests after this was performed. The problem source of the reported product problem was unknown. A root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[183086330]
It was reported that the left chamber failed to produce an accurate reading. The product problem was observed during patient use. The product problem did not cause or contribute to any patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01903 |
| MDR Report Key | 9820805 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2016-06-04 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2019-08-27 |
| 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 | 2020-03-11 |