MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-28 for LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE HW24H NA manufactured by Zhejiang Huawei Scientific Instrument Co Ltd.
| Report Number | 3011816315-2019-00004 |
| MDR Report Key | 8744322 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-28 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-05-26 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2019-06-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR WILLIAM LIANG |
| Manufacturer Street | 237 ZHANGYANG ROAD |
| Manufacturer City | LINHAI, ZHEJIANG 317000 |
| Manufacturer Country | CH |
| Manufacturer Postal | 317000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE |
| Generic Name | TABLETOP HEMATOCRIT CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2019-06-28 |
| Model Number | HW24H |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO LTD |
| Manufacturer Address | 237 ZHANGYANG ROAD LINHAI, 317000 CH 317000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-28 |