MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-25 for G8 021560 manufactured by Tosoh Corporation.
[147063214]
The field service engineer (fse) evaluated the g8 analyzer at the customer's site. Fse performed decontamination of the analyzer which resolved the reported issue. The analyzer was operational. No further action was required by fse.
Patient Sequence No: 1, Text Type: N, H10
[147063215]
This report summarizes 1 malfunction event on the g8 analyzer. The review of the event indicated that the g8 analyzer experienced a retention time error flag. This report was received from one source. 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 | 8031673-2019-00052 |
| MDR Report Key | 8552990 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1058623 |
| Manufacturer G1 | TOSOH CORPORATION |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 1058623 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G8 |
| Generic Name | G8 |
| Product Code | LCP |
| Date Received | 2019-04-25 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH CORPORATION |
| Manufacturer Address | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 105-8623 JA 105-8623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |