MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Bioscience, Inc..
[147062388]
The field service engineer (fse) evaluated the g8 analyzer. The fse replaced several valves and left the analyzer operational. The valves were returned to the tosoh instrument service center (isc). Isc could not duplicate the failures in the reported events.
Patient Sequence No: 1, Text Type: N, H10
[147062389]
This report summarizes 1 malfunction event for the g8 analyzer. The review of the event indicated that the g8 analyzer experienced pressure low error messages, which caused delayed reporting of critical patient results. There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results. This event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005529799-2019-00080 |
| MDR Report Key | 8543683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date Added to Maude | 2019-04-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | 6000 SHORELINE COURT STE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6506368123 |
| Manufacturer G1 | TOSOH BIOSCIENCE, INC. |
| Manufacturer Street | 3600 GANTZ ROAD |
| Manufacturer City | GROVE CITY OH 43123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSOH HLC-723G8 ANALYZER G8 |
| Generic Name | G8 |
| Product Code | LCP |
| Date Received | 2019-04-24 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH BIOSCIENCE, INC. |
| Manufacturer Address | 3600 GANTZ ROAD GROVE CITY OH 43123 US 43123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |