MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-29 for SOMATOM DEFINITION EDGE 10590000 manufactured by Siemens Healthcare Gmbh.
[177149642]
Siemens has completed an investigation of the reported event. The investigation did not reveal a malfunction of the ct system, but a deeper investigation was not possible due to missing log files. Based on the investigation and interview with the facility, it is unknown if the ct collision resulted in the patient's arm fracture or not. No further action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
[177149643]
It was reported to siemens that during a ct scan with the somatom definition edge system the ct gantry collided with the unconscious patient. The patient's arms were taped above the head during the scan and it is unknown if the collision resulted in an arm fracture or if the patient's arm was fractured prior to the scan. This event has been filed with an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2020-13936 |
| MDR Report Key | 9641462 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-02 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-29 |
| 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 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 DEFINITION EDGE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-29 |
| Model Number | 10590000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-01-29 |