MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-06-13 for TOSHIBA DRX-6434HD-H manufactured by Toshiba Corporation.
[21389396]
Ap cardiac x-ray tube caught fire during maintenance by in-house radiology engineering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-1997-00001 |
| MDR Report Key | 99024 |
| Report Source | 05,06 |
| Date Received | 1997-06-13 |
| Date of Report | 1997-06-13 |
| Date of Event | 1997-05-14 |
| Date Facility Aware | 1997-05-14 |
| Report Date | 1997-06-13 |
| Date Mfgr Received | 1997-05-28 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1997-06-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | X-RAY TUBE |
| Product Code | ITY |
| Date Received | 1997-06-13 |
| Model Number | DRX-6434HD-H |
| Catalog Number | DRX-6434HD-H |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 97590 |
| Manufacturer | TOSHIBA CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA SHI TOCHIGI KEN JA 329 26 |
| Baseline Brand Name | TOSHIBA |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE |
| Baseline Model No | DRX-6434HD-H |
| Baseline Catalog No | NA |
| Baseline ID | S/N 97094 |
| Baseline Device Family | DIAGNOSTIC X-RAY TUBE HOUSING ASSEMBLY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-06-13 |