MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for LEVEL 1 H-1200 FAST FLOW FLUID WARMER 8002950 manufactured by Smiths Medical Asd, Inc..
[183479113]
Device evaluation: returned device was received in good physical condition. During the evaluation the device the customer reported condition was confirmed. Problem source was traced to design. Dhr review will not add value to this investigation as this is a known design issue addressed in said capa. This was not reported as an out of box failure.
Patient Sequence No: 1, Text Type: N, H10
[183479114]
Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer was turning on and off by itself. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01974 |
| MDR Report Key | 9833533 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-15 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2020-03-16 |
| 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 | 1265 GREY FOX ROAD |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1 H-1200 FAST FLOW FLUID WARMER |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB |
| Product Code | BSB |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2019-11-12 |
| Model Number | 8002950 |
| 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 | 2020-03-16 |