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..
[183474225]
Device evaluation: returned device was received for evaluation. During the evaluation of the device it was found that the device has a damaged smc elbow connector. The customer reported condition was confirmed. Problem source is unknown. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
[183474226]
Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer had out of box failure ; pressure chamber is not working properly. No patient involvement. After the device was investigated it was determined that the device had a damaged smc elbow connector. The product family hazard analysis indicates that the device in the reported incident is related to a hazardous situation and would likely cause or contribute to a death or serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01908 |
| MDR Report Key | 9833538 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-08-08 |
| 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 | 2019-07-09 |
| 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 |