MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-10 for ADVIA 120 453-0024-15 manufactured by Siemens Healthcare Diagnostics Inc..
[3308276]
The top cover of an advia 120 instrument came in contact with the operators head, while performing daily work responsibilities. The operator completed the shift and did not require medical attention. There are no known reports of intervention or adverse health consequences due to this injury.
Patient Sequence No: 1, Text Type: D, B5
[10349226]
A siemens healthcare diagnostics field service engineer (fse) was dispatched to the customer site for instrument evaluation. After evaluating the instrument, the fse determined the cause for the top cover to not maintain it's upright position was due to a leak in the top cover strut/piston. The fse replaced the top cover struts and the analyzer is operating according to specifications. No further evaluation of the analyzer is required.
Patient Sequence No: 1, Text Type: N, H10
[26369990]
The initial mdr 2432235-2013-00010 was filed on january 10, 2013. Additional information (06/24/2013): an urgent device correction (udc) - udc 10815438 advia 120 optics cover struts, smn 10309266 - was sent to customers in june 2013. The udc notifies customers that if the advia 120 instrument displays a problem when raising and supporting the optics cover, the operator should contact the service provider to arrange to have the cover struts serviced. Siemens field support will be proactively replacing the optics cover hood struts on a regular preventive maintenance schedule. Correction (06/24/13): the catalog number was incorrectly stated as 067-a004 in the initial mdr. The correct catalog number is 453-0024-15.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00010 |
| MDR Report Key | 2908976 |
| Report Source | 05,06 |
| Date Received | 2013-01-10 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-12-14 |
| Date Mfgr Received | 2013-06-24 |
| Device Manufacturer Date | 2009-01-10 |
| Date Added to Maude | 2013-04-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-07/01/2013-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-01-10 |
| Model Number | ADVIA 120 |
| Catalog Number | 453-0024-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-10 |