MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for FLUID WARMING LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES CONSIGNED 115V DOMESTIC H1100 CON-H1100 manufactured by Smiths Medical Asd,inc..
[185195569]
Investigation completed on a smiths medical fluid warming
Patient Sequence No: 1, Text Type: N, H10
[185195570]
Information was received indicating that a smiths medical fluid warming
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02256 |
| MDR Report Key | 9887055 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2020-03-26 |
| 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 Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL NEDERLAND B.V., |
| Manufacturer Street | JAGERSBOSSTRAAT 28, 5241 JT, |
| Manufacturer City | ROSMALEN, NETHERLANDS |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUID WARMING LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-01-06 |
| Model Number | CONSIGNED 115V DOMESTIC H1100 |
| Catalog Number | CON-H1100 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-26 |