MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-01-14 for RAPIDVAC SE3695 manufactured by Covidien Mfg Dc Boulder.
[133041279]
An investigation of the reported condition was performed. A complaint of the device maintaining the suction permanently was reported. The suction should be activated only at the moment when a diathermal burn is performed. One device was received as a service request and a visual inspection and functional test were performed by the field service team. A dhr review was completed for serial# (b)(4). There were no manufacturing issues related to the complaint for this serial number. According to the technician, the unit works as intended. Additionally, the motor was found to be burned and needed replacement. The firmware was already updated to 1. 18. The device as received met the specifications and passed functional testing for the suction capability. It failed for the motor component. This complaint will be considered as unconfirmed for issues with the suction. A root cause for the motor issue is wear and tear. The unit has exceeded its useful life. As part of continuous improvement efforts and a corrective action, the motor was replaced. The device was fully checked for functionality and patient electrical safety according to norm 60601 cl-1 and the manufacturer's guideline. It was deemed technically efficient and safe to use. The unit was cleaned and disinfected according to the manufacturer's guideline. If additional information is received, the investigation will resume as needed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133041280]
According to the reporter, during testing, when the forceps button on the front panel is chosen the device maintains the suction permanently. The suction should be activated only at the moment when a diathermal burn is performed. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2019-00090 |
| MDR Report Key | 8246186 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2019-01-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDVAC |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2019-01-14 |
| Returned To Mfg | 2018-12-19 |
| Model Number | SE3695 |
| Catalog Number | SE3695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-14 |