MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for MULTIX FUSION manufactured by Siemens Medical Solutions Usa, Inc..
[177979311]
Patient was to have a lateral x-ray image. The patient was instructed not to stay in a lateral position and not use the table for support. When the table moved, the patient reached out to the side of the radiology table and their fingers got pinched. The radiology tech noticed in other radiology rooms that when an image is taken, the table locks into position. With this table that is not the case. Patient received small contusion on their hand. Manufacturer response for radiographic systems, (brand not provided) (per site reporter). The vendor has made a suggestion to offer hand rails to prevent such an event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9676477 |
| MDR Report Key | 9676477 |
| Date Received | 2020-02-06 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-10-22 |
| Report Date | 2019-11-04 |
| Date Reported to FDA | 2019-11-04 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX FUSION |
| Generic Name | STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL |
| Product Code | KPR |
| Date Received | 2020-02-06 |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 2501 NORTH BARRINGTON RD HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |