MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-06 for LIGHTCYCLER 2.0 03531414001 manufactured by Roche Diagnostics.
[2101640]
The customer stated that upon entering the laboratory she smelled a strong odor resembling an electrical fire. No smoke was observed. The customer identified the source as coming from their lightcycler 2. 0 (serial number (b)(4)). Security investigated the laboratory and determined there was no electrical fire. The customer did not believe there had been a power surge as none of the other equipment plugged into the same wall had been affected. The customer stated no one was injured. Investigation of the event determined the fan to the power supply stopped working and this caused the power supply to overheat, as a result, the electronic elements burnt and the control unit stopped working. No additional complaints of this nature have been received related to the control unit. The issue is detectable as control unit will stop working immediately. The components are ul certified.
Patient Sequence No: 1, Text Type: D, B5
[9196321]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03631 |
| MDR Report Key | 2151776 |
| Report Source | 05,06 |
| Date Received | 2011-07-06 |
| Date of Report | 2011-07-06 |
| Date of Event | 2011-03-11 |
| Date Mfgr Received | 2011-05-03 |
| Date Added to Maude | 2011-07-06 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | NONNENWALD 2 NA |
| Manufacturer City | PENZBERG 82377 |
| Manufacturer Postal Code | 82377 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTCYCLER 2.0 |
| Generic Name | CHEMISTRY/MICRO ANALYZER |
| Product Code | JJF |
| Date Received | 2011-07-06 |
| Model Number | NA |
| Catalog Number | 03531414001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-06 |