MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-29 for STATSPIN MP X00-003917-001 manufactured by Iris Diagnostics.
[4843693]
Customer noted smoke coming out of the unit.
Patient Sequence No: 1, Text Type: D, B5
[12004736]
Customer reported a burning smell and visible smoke while centrifuge was in use. Upon opening the unit, it was observed that the o-ring had popped out of the rotor and had melted inside the unit. There was no harm due to this incident and no one required medical attention. There were no reports of visible flames nor fire department being called.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00096 |
| MDR Report Key | 4030377 |
| Report Source | 05,06 |
| Date Received | 2014-07-29 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-06-23 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-09-02 |
| 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 | STATSPIN MP |
| Product Code | GKG |
| Date Received | 2014-07-29 |
| Catalog Number | X00-003917-001 |
| 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 DIAGNOSTICS |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-29 |