MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-12-05 for IMX ANALYZER 8389-01 manufactured by Abbott Manufacturing, Inc..
[17038147]
At approx midnight a worker in the facility was performing maintenance on the analyzer when sparks were noted coming from the power cord. While attempting to unplug the analyzer from the wall outlet she was cut and burned on her fingers and sparks went into her face. She was taken to the emergency room where her heart was monitored to determine if she was shocked. Blood work was ordered and she was sent home from work. Add'l info indicates the operator did not have facial burns or eye damage, although her contact lens was cracked in the incident. The account could not provide what intervention was given for the finger cut and burn. The operator still suffers from an occasional headache since the incident. Blood work that was ordered and results are not available. The account states the analyzer was relocated nov 1st by movers to a new location. The operator injured returned to work on 11/13/96. A lab technician stated that a wire was coming out of the plug by the three prong.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1996-00023 |
| MDR Report Key | 54151 |
| Report Source | 05 |
| Date Received | 1996-12-05 |
| Date of Report | 1996-12-04 |
| Date of Event | 1996-11-05 |
| Date Facility Aware | 1996-11-05 |
| Date Mfgr Received | 1996-11-06 |
| Device Manufacturer Date | 1991-04-01 |
| Date Added to Maude | 1996-12-10 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 1996-12-05 |
| Model Number | NA |
| Catalog Number | 8389-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 54728 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-05 |