MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-18 for SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS CON-HL-90 manufactured by Smiths Medical Asd, Inc..
[183964524]
One fluid warmer was returned for evaluation. Visual inspection of the device found it to visable damage, missing components. Old style enclosure, pcb, and drain fitting were noted. The device was powered on and electrical testing performed. The reported customer complaint was noted to be confirmed. The problem source has been determined to be a bad heater assembly as a result of normal wear and tear.
Patient Sequence No: 1, Text Type: N, H10
[183964525]
Information was received that a smiths medical level 1 hotline low flow system will not heat. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02056 |
| MDR Report Key | 9849707 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2006-05-31 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| 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 | SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2019-10-30 |
| Catalog Number | CON-HL-90 |
| 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 N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |