MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-27 for JUPITER SM OPERATING TABLE 4003171 manufactured by Trumpf Medizin Systeme Gmbh + Co. Hg.
[25143723]
According to the investigation, the cause of the table running on its own was damage to the keypad in the remote. This issue is dealt with in the ongoing fsca ((b)(4)). The keypad used was prior to the design change. Trumpf medical has issued safety instructions to the users in the field safety notice and those should be followed until trumpf medical is able to do the final exchange. The operation table and the remote control were checked by service and repaired. Anticipated completion of the fsca is july 2016.
Patient Sequence No: 1, Text Type: N, H10
[25143724]
Trumpf medical received information stating that a jupiter or trusystem 7500 operating table moved independently and without the user deliberately pressing an operating element. No patients or users were injured. This report was filed in our complaint handling system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2015-00009 |
| MDR Report Key | 5037543 |
| Date Received | 2015-08-27 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-08-04 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-08-27 |
| 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 ULBRICH |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | SAALFELD, 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Manufacturer Phone | 9367158641 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JUPITER SM OPERATING TABLE |
| Generic Name | BATTERY POWERED ELECTROMECHANICAL OPERATING TABLE |
| Product Code | FWX |
| Date Received | 2015-08-27 |
| Model Number | 4003171 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDIZIN SYSTEME GMBH + CO. HG |
| Manufacturer Address | CARL-ZEISS STRASSE 7-9 SAALFELD, 07318 GM 07318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-27 |