MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for MAQUET MAGNUS CARBON-FIBRE TABLE TOP 118016A1 manufactured by Kehler Strasse 31.
[57055318]
The incident occurred due to wrong use of the product. There was no product failure. The clinic recognized the wrong usage. This is an isolated case. We are not aware of similar incidents with this type of device. Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.
Patient Sequence No: 1, Text Type: N, H10
[57055319]
It was reported to maquet, that during fluoroscopy, the table 118016a1 (2500mm long) was used with head rest (200mm long), however these are too short to fluoroscope patient? S lower extremity. Arm board was used between the head rest and the mat to lengthen table. The patient was not being secured and was unstable. In a moment, the nurse held the patient and the patient was protected from external injury. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2016-00022 |
| MDR Report Key | 5998941 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-09-05 |
| Date of Event | 2016-09-05 |
| Date Mfgr Received | 2016-09-05 |
| Device Manufacturer Date | 2014-12-15 |
| Date Added to Maude | 2016-10-04 |
| 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 City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer G1 | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAQUET MAGNUS CARBON-FIBRE TABLE TOP |
| Generic Name | TABLE, RADIOLOGIC |
| Product Code | KXJ |
| Date Received | 2016-10-04 |
| Model Number | 118016A1 |
| Catalog Number | 118016A1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEHLER STRASSE 31 |
| Manufacturer Address | RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-04 |