MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-11-01 for KODAK X-OMAT MULTILOADER 300 XML 300 7111958 manufactured by Eastman Kodak Co..
[20136739]
Alleged overheating of dryer heater resulted in smoke and odor from equipment. Following the event, a technician stated that on 9/15/97, she had received an electrical shock while working on dryer section of processor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-1997-00003 |
| MDR Report Key | 130327 |
| Report Source | 05 |
| Date Received | 1997-11-01 |
| Date of Report | 1997-10-23 |
| Date of Event | 1997-09-27 |
| Date Mfgr Received | 1997-10-10 |
| Device Manufacturer Date | 1991-09-01 |
| Date Added to Maude | 1997-11-07 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK X-OMAT MULTILOADER 300 |
| Generic Name | ROOMLIGHT FILM HANDLING EQUIPMENT |
| Product Code | IXW |
| Date Received | 1997-11-01 |
| Model Number | XML 300 |
| Catalog Number | 7111958 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 127458 |
| Manufacturer | EASTMAN KODAK CO. |
| Manufacturer Address | 343 STATE ST. ROCHESTER NY 14650 US |
| Baseline Brand Name | KODAK X-OMAT MULTILOADER 300 |
| Baseline Generic Name | ROOMLIGHT FILM HANDLING EQUIPMENT |
| Baseline Model No | XML 300 |
| Baseline Catalog No | 7111958 |
| Baseline ID | * |
| Baseline Device Family | X-OMAT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K905607 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-01 |