MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-21 for STAT 60 B4360 manufactured by Separation Technology.
[76560]
During centrifugation of coag specimen, cork came out of tube which forced the lid to pop open. Cork flew out of centrifuge. This is the second time this has happened. First occurrence 10/6/97. Unit returned to co & couldn't be reproduced. Unit has been sent back a second time now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012516 |
| MDR Report Key | 133728 |
| Date Received | 1997-11-21 |
| Date of Report | 1997-11-18 |
| Date of Event | 1997-10-06 |
| Date Added to Maude | 1997-11-24 |
| 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT 60 |
| Generic Name | CENTRIFUGE |
| Product Code | GHK |
| Date Received | 1997-11-21 |
| Returned To Mfg | 1997-11-19 |
| Model Number | STAT 60 |
| Catalog Number | B4360 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 130690 |
| Manufacturer | SEPARATION TECHNOLOGY |
| Manufacturer Address | 1096 RAINER DR. ALTAMONTE SPRINGS FL 327143846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-21 |