MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-08 for CYTOFUGE X00-003066-001 manufactured by Iris International.
[5228946]
Customer reported a burning smell with low rpm.
Patient Sequence No: 1, Text Type: D, B5
[12569078]
Burnt electrical smell and centrifuge spinning to slow at 600 rpm was reported. There was no report of exposure to operator or impact to pt results. Add'l complaint investigation reveals no evidence of charred material. There were no reports of injuries, visible flames, charred material, smoke emission, and the fire department was not called. Inadequate centrifugation reported at 600 rpms confirmed by photo tachometer. This may lead to inadequate cells on cytocentrifugation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00168 |
| MDR Report Key | 4272842 |
| Report Source | 07 |
| Date Received | 2014-10-08 |
| Date of Report | 2013-09-23 |
| Date of Event | 2014-09-23 |
| Date Mfgr Received | 2014-09-23 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2014-11-26 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTOFUGE |
| Generic Name | STATSPIN CENTRIFUGE |
| Product Code | IFB |
| Date Received | 2014-10-08 |
| 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 | 2014-10-08 |