MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[32230341]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse replaced the computer. The cause of smoke being emitted from the instrument was related to malfunction of the computer. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[32230342]
The operator on an immulite instrument reported that when the power cord was plugged, the computer's internal power supply sparked and smoked. The operator unplugged the device immediately. There are no reports of injuries, burns or inhalation. There were no reports of adverse health consequences due to the smoke emitted from the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00063 |
| MDR Report Key | 5248743 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-03 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-03 |
| Date Added to Maude | 2015-11-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2015-11-24 |
| Model Number | IMMULITE |
| 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 | 62 FLADERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |