MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for EASY GO VAC PM65 manufactured by Precision Medical Inc..
[56544743]
(b)(6). Subject: easy go aspirator serial # (b)(4). Med watch: (b)(4). Dear (b)(6), the pm65 serial number (b)(4), found with a broken power jack. The history on the device is that it was manufactured in october of 2004, and precision medical shows no record of the device being returned for repair. The device is 12 years old, or twice the recorded life of the product. The likely cause of the complaint, is that the male connector that mates with the device was forced into the connector, braking the female internal power connector. This happens as a result of dropping the device, or the age of the device caused the socket to fail. I would recommend that all pm65 aspirators be checked for this reason, to be sure that the internal battery is being charged. The life of the pm65 aspirator is 5 years. The warranty of the pm65 is 2 years. The life cycle of a lead acid battery is approximately 2 years. I would also recommend that pm65 devices, twice the average life span, be considered for replacement. Any other questions please feel free to contact me. Regards, (b)(4), quality manager, precision medical inc. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56544744]
Event description: audit completed by biomed. Approximately 2 months ago -2 other precision pm65 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 initial audit. Power adapter connector was found to be broken internally preventing charging of the battery or use when plugged into a 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 two will be repaired. The two suction mentioned at sister hospital #1 were a different issue; they had the wrong voltage charger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2016-00002 |
| MDR Report Key | 5986779 |
| Date Received | 2016-09-29 |
| 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 | 2016-08-12 |
| Date Mfgr Received | 2016-08-12 |
| Device Manufacturer Date | 2004-10-04 |
| Date Added to Maude | 2016-09-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES PARKER |
| Manufacturer Street | 300 HELD DRIVE |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Manufacturer G1 | PRECISION MEDICAL INC |
| Manufacturer Street | 300 HELD DRIVE |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18067 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EASY GO VAC |
| Generic Name | PUMP.PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-09-29 |
| Model Number | PM65 |
| Catalog Number | PM65 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | * |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2016-09-29 |