MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-08 for CYTOFUGE X00-003066-001 manufactured by Iris International.
[15322259]
Customer reported the unit speed control did not work after customer replaced a burnt board.
Patient Sequence No: 1, Text Type: D, B5
[15636653]
It was reported that a spillage inside the centrifuge unit led to burning/charring of the board. No injuries reported nor any open flames, smoke, or fire department being called. There was evidence of charring.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00112 |
| MDR Report Key | 4047732 |
| Report Source | 05,06 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-09 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277272 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTOFUGE |
| Generic Name | STATSPIN CENTRIFUGE |
| Product Code | IFB |
| Date Received | 2014-08-08 |
| Catalog Number | X00-003066-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-08 |