MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for GRASEBY? 2000 SYRINGE PUMP RANGE 12D1X100 manufactured by Smiths Medical Asd, Inc..
[113304443]
Information was received that a smiths medical graseby infusion pump had a short circuited, and the pump burnt internally. It was noted to have happened after one hour of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-02581 |
| MDR Report Key | 7660605 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-09 |
| Date Added to Maude | 2018-07-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3RD AVE NO. 26 |
| Manufacturer City | HANGZHOU, 310018 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 310018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GRASEBY? 2000 SYRINGE PUMP RANGE |
| Generic Name | PUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL |
| Product Code | FIH |
| Date Received | 2018-07-03 |
| Catalog Number | 12D1X100 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-03 |