MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-11 for UF1000I manufactured by Sysmex 577.
[20646063]
The instructions for use for this device indicate that the laser is a class i whereas the laser in the device is a class 3b. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[21005398]
Siemens has contacted the manufacturer of this device to inform them of this error.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1217157-2013-00063 |
MDR Report Key | 3071010 |
Report Source | 07 |
Date Received | 2013-04-11 |
Date of Report | 2013-03-27 |
Date of Event | 2013-03-27 |
Date Mfgr Received | 2013-03-27 |
Date Added to Maude | 2013-04-30 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | STEVE ANDBERG |
Manufacturer Street | 2 EDGEWATER DR. |
Manufacturer City | NORWOOD MA 02062 |
Manufacturer Country | US |
Manufacturer Postal | 02062 |
Manufacturer Phone | 7812693655 |
Manufacturer G1 | SYSMEX |
Manufacturer Street | 577 APTAKISIC ROAD |
Manufacturer City | LINCOLNSHIRE IL 60069 |
Manufacturer Country | US |
Manufacturer Postal Code | 60069 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UF1000I |
Generic Name | NONE |
Product Code | LKM |
Date Received | 2013-04-11 |
Operator | OTHER |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SYSMEX 577 |
Manufacturer Address | APTAKISIC ROAD LINCOLNSHIRE IL 60069 US 60069 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-04-11 |