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 2017-07-28 for STATSPIN SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Iris International.
[81328410]
Customer technical specialist (cts) advised customer to return the unit. Customer returned ssvt - 1 centrifuge for investigation. Only the centrifuge was received, rotor was not returned. Upon visual inspection of the centrifuge, noted the hinge on the lid was broken. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81328571]
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 | 2023446-2017-00007 |
| MDR Report Key | 6751302 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-07-17 |
| Device Manufacturer Date | 2010-02-22 |
| Date Added to Maude | 2017-07-28 |
| 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 | 2017-07-28 |
| Model Number | NA |
| Catalog Number | X00-003917-001 |
| Lot Number | NA |
| 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 | 2017-07-28 |