MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-13 for STATSPIN SSVT-1 CENTRIFUGE N/A X00-003917-001 manufactured by Iris International.
[91849145]
Customer technical specialist (cts) advised customer to return the unit. Customer returned ssvt - 1 centrifuge for investigation. Only the centrifuge was received. The power supply, the power extension and the reported broken rotor were not returned. The hinge on the lid was not broken. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91849146]
The customer reported the rt12 rotor broke during centrifugation of the statspin ssvt-1 centrifuge. The customer stated that the safety shield was in use at the time of the event. The customer stated that pieces of the rotor had escaped from the ssvt- 1 centrifuge. There are no reports of harm or injury, no customer exposure, and no medical attention was received due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023446-2017-00009 |
| MDR Report Key | 7025176 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-13 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2017-11-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GOPAL MOHANTY |
| Manufacturer Street | 9172 ETON AVENUE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277379 |
| Manufacturer G1 | IRIS INTERNATIONAL |
| Manufacturer Street | 9172 ETON AVENUE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | FA-24395 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN SSVT-1 CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2017-11-13 |
| Model Number | N/A |
| Catalog Number | X00-003917-001 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVENUE CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |