MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-09-29 for MACHLETT-DYNAMAX 50 * manufactured by Varian X-ray Tube Products.
[115080]
Taken from hosp rpt. "pt on radiology table for x-ray, while exposing for x-ray, the tube failed (blew), oil leaked out and some went into the pts eye, face, upper torso. The radiology tech immediately moved the pt and flushed her eyes with normal saline. All appropriate personnel notified. Environmental services, biomed, engineering, radiology responded. Appropriate spill kits were utilized, area secured. Seen by edmd, attending md and opthamology consultation performed (no signs of any keratitis or conjunctivitis); placed on tobramycin ophthalmic prophylaxis; complete bath given. No complaints of any ophthalmic or skin distress. Discharged home good condition 8/26/98. "per biomed, the initial inspection of the x-ray tube failure occurrence was performed by ge healthcare. Toshiba was also contacted to evaluate the situation and assisted in replacing the tube. Upon eval of the equipment, no abnormalities pertaining to mechanical or electrical operation were found by either ge healthcare or toshiba field svc. There was some concern raised about potential health hazards of the diala-ax oil that leaked from the x-ray tube housing. Under section iii-health info/eye contact for the msds for this product it states "based on essentially similar product testing product is assumed to be nonirritating to the eyes. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717855-1998-00001 |
| MDR Report Key | 189181 |
| Report Source | 00 |
| Date Received | 1998-09-29 |
| Date of Report | 1998-09-23 |
| Date of Event | 1998-08-19 |
| Date Mfgr Received | 1998-08-27 |
| Device Manufacturer Date | 1989-04-01 |
| Date Added to Maude | 1998-09-29 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MACHLETT-DYNAMAX 50 |
| Generic Name | X-RAY TUBE HOUSING ASSEMBLY |
| Product Code | ITY |
| Date Received | 1998-09-29 |
| Returned To Mfg | 1998-08-27 |
| Model Number | DYNAMAX 50 |
| Catalog Number | * |
| 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 | 183851 |
| Manufacturer | VARIAN X-RAY TUBE PRODUCTS |
| Manufacturer Address | 1678 S. PIONEER RD. SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | MACHLETT-DYNAMAX 50 |
| Baseline Generic Name | X-RAY TUBE HOUSING ASSEMBLY |
| Baseline Model No | DYNAMAX 50 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-29 |