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 2019-04-03 for STATSPIN SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Beckman Coulter.
[141225676]
Customer technical support (cts) has provided a replacement ssvt-1 centrifuge. The rotor was not returned for further investigation. Beckman coulter internal identifier is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141225737]
The customer reported rt12 rotor broke resulting in parts escaping from their statspin ssvt-1. The customer noted shield was in used during incident and shield warning sticker was in place. No reports of harm or injury, no customer exposure, and no medical attention was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2019-01063 |
| MDR Report Key | 8480948 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-12-08 |
| Date Facility Aware | 2018-12-08 |
| Date Mfgr Received | 2018-12-08 |
| Device Manufacturer Date | 2007-11-05 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2019-04-03 |
| Returned To Mfg | 2019-01-08 |
| Model Number | SSVT-1 CENTRIFUGE |
| Catalog Number | X00-003917-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |