MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for SONY GOM201SE * manufactured by Sony Electronics Med Sys Div.
[53423]
A technician in the catheterization lab was injured when a 20" television monitor fell off the base of the elevated arm and struck her head in the parietal area. The monitor was held on a pedestal by a nylon cylindrical side measuring 4. 94 cm (1. 93 in) in diameter and 8. 34 mm (0. 328 in) in height. The monitor had been locked into the pedestal by the nylon fingers from the slide. At least one finger was found locked into position. As the technician, striking her in he head. A second monitor, which was still in the box, was used for comparison. The heavy monitor wobbled around the slide when pushed. This application was the wrong use of the type of monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 83246 |
| MDR Report Key | 83246 |
| Date Received | 1997-02-12 |
| Date of Report | 1996-07-26 |
| Date of Event | 1996-07-15 |
| Date Facility Aware | 1996-07-15 |
| Report Date | 1996-07-26 |
| Date Added to Maude | 1997-04-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONY |
| Generic Name | TELEVISION MONITOR |
| Product Code | FWC |
| Date Received | 1997-02-12 |
| Model Number | GOM201SE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 82592 |
| Manufacturer | SONY ELECTRONICS MED SYS DIV |
| Manufacturer Address | 3 PARAGON DR., MAIL DROP S200 MONTVALE NJ 076451725 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-12 |