MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-25 for STATSPIN MP X00-003917-001 manufactured by Iris International.
[5194731]
Customer reported that the motor shaft broke.
Patient Sequence No: 1, Text Type: D, B5
[12503175]
It was reported that the rotor holder shaft broke off causing the rotor to detach from the motor during analysis. The rotor and specimen were contained inside the centrifuge. There was no report of any impact to patient samples. There were no reports of exposure of biohazardous to user, injury, or delay in patient results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00179 |
| MDR Report Key | 4307595 |
| Report Source | 07 |
| Date Received | 2014-11-25 |
| Date of Report | 2013-11-06 |
| Date of Event | 2014-11-06 |
| Date Mfgr Received | 2014-11-06 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2014-12-12 |
| 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 |
| Generic Name | STATSPIN CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2014-11-25 |
| 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 INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-25 |