MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for TRUSYSTEM 7000 DV TS7000DV 1723633 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[146633114]
During inspection, the technician found no problems with the table. However, he discovered damage to the remote's display screen. No repairs or replacements were completed. A review of the table data logs is currently in progress. A follow-up report will be submitted if any new information is discovered.
Patient Sequence No: 1, Text Type: N, H10
[146633115]
During a procedure, a trumpf medical trusystem 7000 dv operating table was being articulated into trendelenburg position, when the column lowered on its own. The account reported that there were no injuries to the patient nor impact to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007143268-2019-00007 |
| MDR Report Key | 8647416 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2014-07-14 |
| Date Added to Maude | 2019-05-28 |
| 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 | MR. STEFFEN STEFFEN ULBRICH |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | SAALFELD, 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSYSTEM 7000 DV |
| Generic Name | 7000 DV |
| Product Code | JEA |
| Date Received | 2019-05-28 |
| Model Number | TS7000DV |
| Catalog Number | 1723633 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Address | CARL-ZEISS STRASSE 7-9 SAALFELD, 07318 GM 07318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |