MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for EASY GO VAC PM65HG manufactured by Precison Medical, Inc..
[60660422]
Patient Sequence No: 1, Text Type: N, H10
[60660423]
These aspirators behave as if the battery is low/discharge when turning the unit on. Biomed tech called tech support and also looked at the operator's manual with no indication of the error we were experiencing. After opening the unit, it was noticed that there was a blown fuse. After the fuse was replaced, the unit started to work normal again. Since then, we have identified at least 7 more devices with the same problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6120328 |
| MDR Report Key | 6120328 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-11-07 |
| Report Date | 2016-11-07 |
| Date Reported to FDA | 2016-11-07 |
| Date Reported to Mfgr | 2016-11-07 |
| Date Added to Maude | 2016-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | EASY GO VAC |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-11-22 |
| Model Number | PM65HG |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISON MEDICAL, INC. |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |