MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for DIMENSION EXL 200 10636929 manufactured by Siemens Healthcare Diagnostics Inc..
[185577008]
The customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument. Cse confirmed that the fire was from the printer and replaced the system printer. System was fully functional upon departure. The drain for the analyzer was not fully inserted into the drain and the fluid made contact with the printer power cable. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[185577009]
Customer reported seeing smoke and fire from their dimension exl 200 instrument. The smoke came from the printer. There was no delay in patient testing and no known reports of impact to patient test results. There are no known reports of patient intervention or adverse health consequences due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2020-00114 |
| MDR Report Key | 9899349 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIC SO |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 5243067 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD REGISTRATION #: 2247117 |
| Manufacturer City | FLANDERS, NJ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION EXL 200 |
| Generic Name | DIMENSION EXL 200 |
| Product Code | JJE |
| Date Received | 2020-03-30 |
| Model Number | DIMENSION EXL 200 |
| Catalog Number | 10636929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK, DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |