MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-01-13 for BIAD XLT 2500 manufactured by Trionix Research Laboratory, Inc..
[16280612]
While 67 year old male was being scanned, head 2 detector dropped and touched pt, pt was examined at the hosp, no injuries were found. Apparently the radius ball screw broke at the junction of the motor, allowing the detector to drop downward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527587-1997-00001 |
| MDR Report Key | 62352 |
| Report Source | 00 |
| Date Received | 1997-01-13 |
| Date of Report | 1997-01-09 |
| Date of Event | 1997-01-03 |
| Date Mfgr Received | 1997-01-03 |
| Device Manufacturer Date | 1994-04-01 |
| Date Added to Maude | 1997-01-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIAD XLT |
| Generic Name | NUCLEAR DIAGNOSTIC IMAGING CAMERA |
| Product Code | JWM |
| Date Received | 1997-01-13 |
| Model Number | BIAD XLT |
| Catalog Number | 2500 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 62668 |
| Manufacturer | TRIONIX RESEARCH LABORATORY, INC. |
| Manufacturer Address | 8037 BAVARIA RD TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-13 |