MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-17 for PRECISION MEDICAL INC. PM65 manufactured by Precision Medical Inc..
[57687152]
(b)(6). Subject: easy go aspirator serial # (b)(4). Med watch (b)(4). Dear (b)(4), the pm65 serial number (b)(4), complaint of getting hot and smoking. The history on the device is that it was manufactured in december of 1999, and precision medical shows no record of the device being returned for repair. The device is 16 years old, or three times the recorded life of the product. The likely cause of the complaint, is that the lead acid battery contained in the device, over heated, when the fluid leaked out. This caused the smell and smoke. I would recommend that all pm65 aspirators older than 5 years, be serviced, and at the very least the batteries should be replaced if older than 2 years. 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, three times the average life span, be considered for replacement. Any other questions please feel free to contact me. Regards, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57687153]
Event desc: the unit began to smoke and create an acid bad odor and the unit was extremely hot to touch. This incident occurred at approximately 4:40 pm 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 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 has 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 | 2523148-2016-00003 |
| MDR Report Key | 6034053 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-17 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-06-30 |
| Report Date | 2016-07-01 |
| Date Reported to FDA | 2016-07-01 |
| Date Mfgr Received | 2016-08-19 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2016-10-17 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 18067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18067 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL INC. |
| Generic Name | PM65 EASY GO VAC |
| Product Code | BTA |
| Date Received | 2016-10-17 |
| Model Number | PM65 |
| Catalog Number | PM65 |
| Lot Number | NA |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | Y |
| Device Age | 16 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL INC. |
| Manufacturer Address | 300 HELD DR NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-17 |