MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for C1000 (TOUCH) THERMAL CYCLER CHASSIS manufactured by Bio-rad.
[49801286]
On (b)(6) 2016, (b)(6) staff reports, heard popping coming from thermal cycler. Unit started sparking and smoking. Sparks and flames were near the power switch. Unit serial number (b)(4). Unit returned to bio-rad for repair. According to bio-rad the malfunction that caused the sparks, popping noise and flames is due to a defective power supply. Bio-rad did not issue a recall because of a less than (b)(4) failure rate, and thought that issue is contained to a power supply enclosure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063473 |
| MDR Report Key | 5802101 |
| Date Received | 2016-07-18 |
| Date of Report | 2016-07-12 |
| Date of Event | 2016-06-08 |
| Date Added to Maude | 2016-07-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C1000 (TOUCH) THERMAL CYCLER CHASSIS |
| Generic Name | THERMAL CYCLER |
| Product Code | OUL |
| Date Received | 2016-07-18 |
| Model Number | C1000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD |
| Manufacturer Address | 255 LINUS PAULING DRIVE HERCULES CA 94547 US 94547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-18 |