MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-28 for TEG? 5000 THROMBELASTOGRAPH? HEMOSTASIS ANALYZER 07-033 manufactured by Haemonetics Corporation.
[181541113]
The field service technician inspected the device and replaced all electrical components and columns. The field service technician also performed all functional tests and confirmed that all functions passed. The unit is operating within manufacturing standards.
Patient Sequence No: 1, Text Type: N, H10
[181541194]
On (b)(6) 2019 haemonetics was informed that during a quality check (qc) a teg analyzr, 5000, 60hz, fg started smoking and turned itself off. The analyzer was then unplugged. A patient was not at the time the event occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00002 |
| MDR Report Key | 9636263 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-28 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2019-12-03 |
| Device Manufacturer Date | 2014-09-22 |
| Date Added to Maude | 2020-01-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SHAUN FLANAGAN |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal | 02110 |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEG? 5000 THROMBELASTOGRAPH? HEMOSTASIS ANALYZER |
| Generic Name | TEG ANALYZER, 5000, 230V, 50HZ, FG |
| Product Code | JPA |
| Date Received | 2020-01-28 |
| Model Number | 07-033 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION |
| Manufacturer Address | 125 SUMMER STREET BOSTON MA 02110 US 02110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |