MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-07 for AUTOCRIT ULTRA-3 DIRECT-READING CENTRIFUGE * 420575 manufactured by Bdds.
[757796]
Customer was using the autocrit ultra 3 centrifuge. Customer heard a loud pop and dropped to the floor. The centrifuge lid came open and debris came out of centrifuge. No one was injured by the flying debris but, the technologist strained his neck when he dropped to the floor and had to seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[8037058]
Investigation of the returned centrifuge showed extensive damage to the lid. The lid is unable to close or latch. Internal parts, headcover and carrying tray, are too damaged to provide further info. All large metal pieces were intact and suffered no damage. Multiple explosion tests were conducted to duplicate this issue. In order to reproduce this type of incident the headcover, which is an internal component, had to be severely damaged before it would break apart and cause the lid to open. There have been no other documented complaints for this type of issue. Bd will continue to monitor this type of issue for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2007-00006 |
| MDR Report Key | 961595 |
| Report Source | 05 |
| Date Received | 2007-05-07 |
| Date of Report | 2007-05-04 |
| Date of Event | 2007-04-04 |
| Date Mfgr Received | 2007-04-04 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2007-12-11 |
| 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 | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCRIT ULTRA-3 DIRECT-READING CENTRIFUGE |
| Generic Name | GKG |
| Product Code | GKG |
| Date Received | 2007-05-07 |
| Returned To Mfg | 2007-04-12 |
| Model Number | * |
| Catalog Number | 420575 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 931519 |
| Manufacturer | BDDS |
| Manufacturer Address | * SPARKS MD * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-07 |