MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-09-11 for MULTIX TOP 00475509 manufactured by Siemens Ag.
[17950802]
It was reported that a (b)(6) year old male pt was presented to the facility for an x-ray of a hand. The pt was sitting in a wheelchair on the side of the multix top system table with his legs under the table. The operator was behind the folding screen when the table started descending on the pt's thighs without any given commands. The operator stopped the downward movement by pressing the red emergency stop button. The pt sustained no injury and did not require any medical attention. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[18120189]
The operator manual for multix top system (axb1-150. 620. 01. 01. 02) contains warnings regarding collision/crushing zones. The reported issue is under investigation and a supplemental report will be submitted once additional information has been received. This report was submitted (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2013-07181 |
| MDR Report Key | 3843098 |
| Report Source | 01,07 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-08-14 |
| Date Added to Maude | 2014-06-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY MS D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTR.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 | MULTIX TOP |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | IZZ |
| Date Received | 2013-09-11 |
| Model Number | 00475509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | WITTELSBACHERPLATZ MUNICH 80333 GM 80333 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-11 |