MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[39426733]
The cse was at the customer site to resolve "carousel temperature" errors which shut the system down. The cse checked the system and found voltage fluctuations. The cse installed a new power supply, verified all voltages, primed the system and ran a water test. The cse also replaced the diluter assembly. The customer ran quality controls, which resulted within acceptable range. The cause of smoke being emitted from the instrument is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[39426734]
A siemens customer service engineer (cse) reported that smoke was emitted from an immulite instrument after performing troubleshooting on the system and installing new parts. The cse checked the system and found that wires were overheated. There are no reports of injuries, fire, 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
[41330442]
The initial mdr 2247117-2016-00008 was filed on february 23, 2016. Additional information (01/26/2016): the overheated wires were found in the harness from the mother printed circuit board to the diluter assembly. The siemens customer service engineer (cse) replaced the harness to diluter and the mother printed circuit board. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[41332411]
The initial mdr 2247117-2016-00008 was filed on february 23, 2016. Supplemental mdr 2247117-2016-00008_s1 was filed on february 23, 2016. Additional information (01/26/2016): the cause of smoke being emitted from the instrument was overheating of wire insulation. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2016-00008 |
| MDR Report Key | 5453121 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-26 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-01-26 |
| Date Added to Maude | 2016-02-23 |
| 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 | 3 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2016-02-23 |
| Model Number | IMMULITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-02-23 |