MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-19 for MULTIX MT 08395399 NA manufactured by Siemens Healthcare Sector.
[4039227]
It was reported that while servicing the multix unit, a siemens engineer noticed the rollers on the 3d top ceiling stand moved more than 50% out of the rail. The securing pins for the transverse bridge assembly were sticking out and not locking the transverse rail to the transverse bridge assembly, thereby allowing the transverse rails to drift. Although there have been no report of any injuries in this event, the whole 3d assembly could potentially crash down during an examination.
Patient Sequence No: 1, Text Type: D, B5
[11352115]
The system is equipped with safety features such as spacer sleeves and securing pins to prevent the described condition. However, in the reported case, the securing pins were found to be outside of the designated space. The securing pins are installed at the factory and the assembly is delivered completely mounted. It is assumed that the securing pins were removed during system installation at the facility. The engineer reinstalled the securing pins and repositioned the transverse bridge assembly to secure the system. To ensure that the system is installed according to the specifications, a specialist will visit the facility to certify the unit. This report was submitted on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2013-09461 |
| MDR Report Key | 3496452 |
| Report Source | 07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-10-21 |
| Date Mfgr Received | 2013-10-21 |
| Date Added to Maude | 2014-01-02 |
| 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 | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX MT |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2013-11-19 |
| Model Number | 08395399 |
| Catalog Number | NA |
| Lot Number | NA |
| 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 HEALTHCARE SECTOR |
| Manufacturer Address | 51 VALLEY STREAM PKWY. MS D02 MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-19 |