MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-12-05 for PUMP VAC BLDC 24V 220250010 manufactured by Integra Lifesciences Ireland Limited.
[4066102]
It was reported that when the cusa was switched on, there was a burning smell coming from the unit. The cusa console was opened and on inspection it was found that a few components on the driver control board of the suction pump were burned and it was also observed that suction pump was not working. There was no patient contact or injury involved with this event.
Patient Sequence No: 1, Text Type: D, B5
[11534014]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006697299-2013-00078 |
| MDR Report Key | 3599635 |
| Report Source | 01,08 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-12-05 |
| Date Mfgr Received | 2013-11-13 |
| Date Added to Maude | 2014-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP VAC BLDC 24V |
| Generic Name | NA |
| Product Code | LBK |
| Date Received | 2013-12-05 |
| Catalog Number | 220250010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES IRELAND LIMITED |
| Manufacturer Address | SRAGH TULLAMORE, CO. OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-05 |