MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for BERKELEY VACUUM CURETTAGE VC-2 manufactured by Berkeley Medevices.
[181156823]
Unit deactivated on its own during use on postpartum patient with hemorrhage. Machine was tested twice before use on patient and was working. During suctioning of blood clots from patient, machine stopped. Staff attempted to turn machine off and on, even unplugged and replugged multiple times in different outlets in the room. Machine did not turn back on. Another machine was brought into the room. Staff concerns with no trouble shooting abilities than two functions - plug in and pull knob and for device to stop working mid procedure with a hemorrhaging patient. Malfunctioned device was reviewed by biomed and noted unit had a tripped circuit breaker. Biomed was able to identify after automatic shut down due to clots, it would shut down. But problem associated with machine, no ability to turn back on. Identified machine had to be disassembled to switch back on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9762842 |
| MDR Report Key | 9762842 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-10-18 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | BERKELEY VACUUM CURETTAGE |
| Generic Name | SYSTEM, ABORTION, VACUUM |
| Product Code | HHI |
| Date Received | 2020-02-27 |
| Model Number | VC-2 |
| Catalog Number | VC-2 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERKELEY MEDEVICES |
| Manufacturer Address | 1330 SOUTH 51ST ST. RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |