MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-10 for MAGNUS CARB.-FIBRE TABLE TOP, LONG 118016A2 - MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLU 118016A2 manufactured by Maquet Gmbh.
[174942767]
It was reported that the carbon table top was damaged. A getinge? Maquet service technician was on site and inspected the product in question. It was detected that edges of the carbon table top were chipped off. This kind of damage is caused due to collision of the table top and obstacles under the table top or when colliding with obstacles against the table top. In the instructions for use (ifu) the user is warned concerning the risks related to collisions and advised as follows: "during the adjustment procedures, always pay attention to the or table and accessories and avoid collisions. Ensure that tubes, cables and drapes are not trapped. " besides the user is told in the ifu not to use a defective product. We assume that this issue occurred due to a use error. The product was damaged due to a use error and afterwards the product was used despite the mentioned damages. No serious injury or required medical intervention was reported. Since the extent of the reported cut is unknown, we err on the side of caution and report this as serious injury. Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report. The complete event site name is queen elizabeth university hospital glasgow and the postal code is g51 4tf.
Patient Sequence No: 1, Text Type: N, H10
[174942768]
It was reported that the table top was damaged due to a collision. A user has cut his or her hand on the damaged surface during cleaning. Manufacturer reference# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2020-00002 |
| MDR Report Key | 9574991 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2014-04-15 |
| Date Added to Maude | 2020-01-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer G1 | HOLGER ULLRICH |
| Manufacturer Street | MAQUET GMBH 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 | 3 |
| Brand Name | MAGNUS CARB.-FIBRE TABLE TOP, LONG |
| Generic Name | TABLE, RADIOLOGIC |
| Product Code | KXJ |
| Date Received | 2020-01-10 |
| Model Number | 118016A2 - MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLU |
| Catalog Number | 118016A2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-10 |