MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-18 for STATSPIN MP X00-004998-001 manufactured by Iris International.
[5593828]
Customer reported rotor broke into pieces.
Patient Sequence No: 1, Text Type: D, B5
[13058910]
Customer reported a rt12 rotor was broken into pieces on their statspin mp unit; however, pieces were contained inside the unit. There was no report of exposure to the operator or impact to patient results. The customer decides not to return for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2015-00059 |
| MDR Report Key | 4632064 |
| Report Source | 05,06 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-02-19 |
| Date of Event | 2015-02-19 |
| Date Mfgr Received | 2015-02-19 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2015-05-07 |
| 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 | GOPAL MOHANTY |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277379 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN MP |
| Product Code | GKG |
| Date Received | 2015-03-18 |
| Catalog Number | X00-004998-001 |
| 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 | 2015-03-18 |