MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-13 for BECKMAN IRIS STATSPIN M510 EXPRESS4 manufactured by Beckman Coulter.
[14874837]
Beckman iris statspin model m510 express4 centrifuge's rotor shattered during operation on (b)(6) 2014. Two other events within (b)(6) healthcare happened with the same product; on (b)(6) 2014. Specimens lost, no operator injury reported. Complaint filed with mfr obtained ref. # (b)(4). Broken rotor to centrifuge while in operation. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036138 |
| MDR Report Key | 3820383 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-03-05 |
| Date Added to Maude | 2014-05-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN IRIS STATSPIN |
| Generic Name | BECKMAN IRIS STATSPIN |
| Product Code | GKG |
| Date Received | 2014-05-13 |
| Model Number | M510 EXPRESS4 |
| ID Number | 402874823, AC153108 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-13 |