MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-15 for LEVEL 1? HOTLINE? LOW FLOW SYSTEM DI-60HL manufactured by Smiths Medical Asd; Inc..
[179716178]
Information was received indicating that immediately after powering on a smiths medical level 1? Hotline? Low flow system, the water did not circulate. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01129 |
| MDR Report Key | 9715086 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-15 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-02-15 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD; INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? HOTLINE? LOW FLOW SYSTEM |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2020-02-15 |
| Returned To Mfg | 2020-01-24 |
| Model Number | DI-60HL |
| Catalog Number | DI-60HL |
| Lot Number | 3851262 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-15 |