MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-13 for HETTICH CENTRIFUGE 1701-30 manufactured by Andreas Hettich Gmbh & Co. Kg.
[18919773]
Customer reported on (b)(6) 2014 that hettich 380 centrifuge stopped working. The unit was returned to bd for investigation. During investigation on (b)(6) 2014, it was noted that the instrument was charred on the back and had a melted plug receptacle. Technical service contacted the customer for further details. The customer stated that after the centrifuge started it's second spin there was a spark and smoke but no fire. They unplugged the unit and contacted their maintenance department to check the outlets in the lab. No issues were found and customer stated it was plugged into the correct volt outlet. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
[19277940]
Bd noted the returned centrifuge showed signs of having an electrical issue on the outside of the instrument around the plug area that was not originally reported by the customer. The instrument was charred on the back and had a melted plug receptacle. The inside of the centrifuge did not show any signs of burning or damage. The plug receptacle with suppression filter functioned as designed and protected the internal electronics of the centrifuge. The plug got hot enough to melt inside of the receptacle on the centrifuge. Quality determined during the investigation that the centrifuge was being run at the customer site without the motor cover in place, which allowed fluid to get inside of the motor from the top. This is believed to be the root cause of the failure. It is unknown why the cover was removed. The centrifuge vendor was contacted for further information and confirmed they have no trends on this type of failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00011 |
| MDR Report Key | 3952396 |
| Report Source | 05 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-02-18 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-02-18 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | ANDREAS HETTICH GMBH & CO. KG |
| Manufacturer Street | FOEHRENSTRASSE 12 |
| Manufacturer City | TUTTLINGEN D-78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HETTICH CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2014-05-13 |
| Returned To Mfg | 2014-03-18 |
| Model Number | 1701-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDREAS HETTICH GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN D-78532 GM D-78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-13 |