MAUDE Adverse Event Report: PRECISION MEDICAL EASY GO VAC ASPIRATOR; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number PM65

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585); Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: EASY GO VAC ASPIRATOR
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): PRECISION MEDICAL; 300 held drive; northampton, PA 18067
• MDR Report Key: 5836838
• MDR Text Key: 50857514
• Report Number: 5836838
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2016,07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2016
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1