MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-06-17 for MULTIX TOP 00475509 manufactured by Siemens Ag.
[2118358]
It was reported that during a study on multix top patient's fingertip got injured and required further surgical treatment. Additionally, it was reported that the event was caused by the user accidently pressing on the system footswitch. The described event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9168800]
The operator manual for multix top system (b)(4) contains chapter on general safety and informs about risk of collision and possible crushing zones. If the customer follows the procedure, a death or serious injury is unlikely. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2011-00019 |
| MDR Report Key | 2142301 |
| Report Source | 01 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-05-24 |
| Date Mfgr Received | 2011-05-27 |
| Date Added to Maude | 2011-07-05 |
| 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 D-02 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX TOP |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2011-06-17 |
| Model Number | 00475509 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2011-06-17 |