MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-03 for SERIES 8000 BUCKY LF 8000 UNKNOWN manufactured by Liebel Flarsheim.
[4094]
It was reported to g. E. That the bucky tray pulled out out of the bucky because the stops had failed on the bucky. Apparently, this resulted in the tray landing on the toe of the service engineer, which was then fractured. Evidently, the metal tab on the bucky assembly had broken off. The injury resulted in lost work days by the service engineer. Device not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: distributor. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: mechanical problem, other. Conclusion: device failure indirectly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, inserviced by manufacturer/distributor representative. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1993-00006 |
| MDR Report Key | 6183 |
| Date Received | 1993-06-03 |
| Date of Report | 1993-05-10 |
| Date of Event | 1993-05-05 |
| Date Facility Aware | 1993-05-05 |
| Report Date | 1993-05-10 |
| Date Reported to FDA | 1993-05-10 |
| Date Reported to Mfgr | 1993-05-05 |
| Date Added to Maude | 1993-08-10 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERIES 8000 BUCKY |
| Generic Name | X-RAY TABLE BUCKY |
| Product Code | IXQ |
| Date Received | 1993-06-03 |
| Model Number | LF 8000 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 01-FEB-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5872 |
| Manufacturer | LIEBEL FLARSHEIM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-06-03 |