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 2019-12-04 for SOMATOM DRIVE 10431700 manufactured by Siemens Healthcare Gmbh.
[169263913]
(b)(6). Siemens has initiated a technical investigation of the complaint jaw spanner tool. The root cause is not yet available. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[169263914]
It was report to siemens that the service engineer sustained a laceration while servicing the somatom drive with a jaw spanner tool. This tool was delivered with the system drive motor top support for the patient table (phs). The service engineer reported when the belt pulley to the motor is tightened, the tool is used to hold the nut and becomes pressed towards the fundament of the phs because of the torque tightening on the screw of the belt pulley. When the engineer needed to loosen the tool, it slipped and lacerated his thumb. It was further reported that the complaint tool has very sharp edges. The injury was reported as a 1-2 cm deep laceration on the side of the engineer's right thumb. The wound was treated at the emergency department next to the ct area and was closed with three sutures. No additional health consequences or treatment were reported. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-08614 |
| MDR Report Key | 9413351 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-04 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2019-12-04 |
| 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 Contact | REBECCA TUDOR |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN, PA PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486484 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSTRASSE 1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATOM DRIVE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2019-12-04 |
| Model Number | 10431700 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSTRASSE 1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-04 |