MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for SEDECAL NOVA FA manufactured by Sedecal Sa.
[112756876]
The two cables and pulley were taken to sedecal the same morning of may 25th for a deeper analysis. The rest of the damaged equipment, once removed, was taken to sedecal facilities for further investigation. On monday may 28th, we proceeded to assemble the pulley removed in a similar equipment existing at sedecal facilities. When operating the equipment in such conditions, an unusual noise was detected in the vertical movement. Once the cause of this was analyzed, it was found that the noise was due to friction between the two steel cables, which had come into contact due to the greater wear produced in one of the grooves of the pulley in question we will communicate to all customers a mandatory review of the entire installed base by the various technical services to verify the status of this pulley and the two steel cables, proceeding to change them in case of detecting any deterioration in the cables or irregular or excessive wear of the pulley.
Patient Sequence No: 1, Text Type: N, H10
[112756877]
This incident involves a malfunction in a diagnostic x-ray system, specifically the overhead tube crane. This is a ceiling mounted device which holds the x-ray tube and the collimator. This assembly can be moved both horizontally and vertically. In this case, the assembly fell to the ground without any command from the operator to do this. Had there been a person underneath the tube crane at the time, that person could have been severely injured or killed because of the mass involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617251-2018-00001 |
| MDR Report Key | 7633941 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-25 |
| Date Added to Maude | 2018-06-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARIA GOMEZ |
| Manufacturer Street | PELAYA, 9 . POL. IND. RIO DE JANEIRO |
| Manufacturer City | ALGETE, MADRID 28110 |
| Manufacturer Country | SP |
| Manufacturer Postal | 28110 |
| Manufacturer G1 | SEDECA; SA |
| Manufacturer Street | PELAYA 9 POL. IND. "RIO DE JANEIRO" |
| Manufacturer City | ALGETE, MADRID 28110 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SEDECAL |
| Generic Name | DIAGNOSTIC X-RAY OVERHEAD TUBE STAND |
| Product Code | IYB |
| Date Received | 2018-06-25 |
| Model Number | NOVA FA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDECAL SA |
| Manufacturer Address | PELAYA, 9 . POL. IND. RIO DE JANEIRO ALGETE, MADRID 28110 SP 28110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-25 |