MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-25 for STATSPIN EXPRESS 4 * manufactured by Iris Sample Processing.
[20008110]
The statspin centrifuge had a broken latch mechanism that did not prevent the lid from opening while samples were spinning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3428871 |
| MDR Report Key | 3428871 |
| Date Received | 2013-09-25 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-07-17 |
| Report Date | 2013-09-25 |
| Date Reported to FDA | 2013-09-25 |
| Date Reported to Mfgr | 2013-10-25 |
| Date Added to Maude | 2013-10-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN EXPRESS 4 |
| Generic Name | CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2013-09-25 |
| Model Number | STATSPIN EXPRESS 4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS SAMPLE PROCESSING |
| Manufacturer Address | 60 GLACIER DRIVE WESTWOOD MA 02090 US 02090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-25 |