MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-22 for STATSPIN MP X00-004998-001 manufactured by Iris International.
[5285607]
Customer reported the unit was smoking.
Patient Sequence No: 1, Text Type: D, B5
[12632004]
The customer reported smoke from their mp centrifuge. There were no report of flames and the fire department was not called. The customer stated an employee was exposed to the smoke; however, there were no reports of any injury, or impact or operator, or impact to pt results as a result of this event. The unit was returned to the manufacturer for further evaluation where it was determined an electronic component on the pcb burned and slightly melted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00194 |
| MDR Report Key | 4365964 |
| Report Source | 07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-11 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-01-08 |
| 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 GUTPA |
| 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 | STATSPIN MP |
| Generic Name | STATPIN CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2014-12-22 |
| Returned To Mfg | 2014-12-11 |
| Catalog Number | X00-004998-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-12-22 |