MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-28 for EASY GO VAC PM65HG manufactured by Precision Medical, Inc..
[50626371]
Patient Sequence No: 1, Text Type: N, H10
[50626372]
Audit completed by biomed approximately 2 months ago - 2 other precision pm65 portable suction machines not functioning correctly, with same issue, found in 2 different units. An audit at sister hospital #1 found 2 portable suction machines not functioning correctly. No defective units found at sister hospital #2 as of 2 weeks after the initial audit. Power adapter connector was found to be broken internally preventing charging of the battery or use when plugged into an ac outlet. This indication would not be observable from the outside of the device. The connector will be replaced. During further investigation of our fleet of portable suctions: two additional devices were found with the same issue; these too will be repaired. The two suctions mentioned at sister hospital #1 were a different issue; they had the wrong voltage chargers. These will be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5828843 |
| MDR Report Key | 5828843 |
| Date Received | 2016-07-28 |
| Date of Report | 2016-06-28 |
| Date of Event | 2016-04-17 |
| Report Date | 2016-06-28 |
| Date Reported to FDA | 2016-06-28 |
| Date Reported to Mfgr | 2016-06-28 |
| Date Added to Maude | 2016-07-28 |
| 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 |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-07-28 |
| Model Number | PM65HG |
| ID Number | 25924 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON, PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-28 |