MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-26 for AXIOM MULTIX MT 08395399 manufactured by Siemens Ag.
[19194884]
It was reported that a female patient was holding to the edge of the table while sitting on the tabletop on the axiom multix mt system. The table moved and the patient's finger got caught between the bucky and the table top. The patient suffered a fracture to her 5th (pinky) finger on the left hand. The patient sought medical attention at the orthopedic department of the facility. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[19478325]
Preliminary investigation showed that the table brakes were activated when the incident occurred. The breaking force of the table was too low potentially causing the table to move. The incident is under investigation. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2012-11354 |
| MDR Report Key | 2885433 |
| Report Source | 01,07 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-06 |
| Date of Event | 2012-12-05 |
| Date Mfgr Received | 2012-12-06 |
| Date Added to Maude | 2012-12-26 |
| 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 | AXIOM MULTIX MT |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2012-12-26 |
| Model Number | 08395399 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-26 |