MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-01-29 for QBC CENTRIFUGE 424740 manufactured by Becton Dickinson.
[335127]
Becton dickinson received customer complaint that a qbc autoread centrifuge power pack caught fire. Customer commented that the fire was small and went out by itself. Customer did not contact fire dept. Damage to the equipment only. No injuries resulted from the event. Report being filed based on a malfunction that if it were to recur may result in an injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2004-00001 |
| MDR Report Key | 516354 |
| Report Source | 05,06 |
| Date Received | 2004-01-29 |
| Date of Report | 2004-01-22 |
| Date of Event | 2003-12-22 |
| Date Mfgr Received | 2003-12-22 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 2004-03-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QBC CENTRIFUGE |
| Generic Name | CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2004-01-29 |
| Model Number | NA |
| Catalog Number | 424740 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 505378 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US |
| Baseline Brand Name | QBC CENTRIFUGE |
| Baseline Generic Name | CENTRIFUGE |
| Baseline Model No | NA |
| Baseline Catalog No | 424740 |
| Baseline ID | SN - 3100173 |
| Baseline Device Family | POINT OF CARE HEMATOLOGY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K813033 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-29 |