MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-01 for EASY GO VAC ASPIRATOR PM65 manufactured by Precision Medical.
[50857513]
Patient Sequence No: 1, Text Type: N, H10
[50857514]
The unit began to smoke and create an acidic bad odor and the unit was extremely hot to touch. This incident occurred at approximately 4:40pm and even after 15 minutes the unit was still warm to touch. After being persuasive, i was able to get the battery out of the unit; on further inspection, i noticed that the charging circuit board was burnt so it must have shorted out. Honestly, because the case is melted and distorted and the charging circuit for the unit is compromised, i believe that this unit is beyond repair and should be replaced. I will call the manufacturer and see if there have been any instances of this happening and i will also try to get a price on a replacement unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5836838 |
| MDR Report Key | 5836838 |
| Date Received | 2016-08-01 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-06-30 |
| Report Date | 2016-07-22 |
| Date Reported to FDA | 2016-07-22 |
| Date Reported to Mfgr | 2016-07-22 |
| Date Added to Maude | 2016-08-01 |
| 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 |
| 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 ASPIRATOR |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-08-01 |
| Model Number | PM65 |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON, PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-01 |