EASY GO VAC ASPIRATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for EASY GO VAC ASPIRATOR manufactured by Precision Medical.

Event Text Entries

[102213111] Our biomedical tech received a work order at 7:02 about a "battery for the suction machine on crash cart is over heating. " i called staff member about the work order she had submitted and asked her about the situation. She said when they came in to work, the hallway leading to the mri smelled like something was burning. She thought there might be fire, so she quickly went to the back and noticed it was from the aspirator. This is when she unplugged the unit and submitted a work order. I then went to the department and assessed the situation. The case on the aspirator was melted and battery acid was leaking out. I removed it from the department and call precision medical for guidance. I explained the situation to customer service and she said that the unit is no longer covered under warranty and that i can send the unit in for repair. I asked her for the preventive maintenance guidelines for replacing batteries because in the manual they do not have recommendations. She said they do not have any replacement intervals. I did not get further assistance from them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075796
• MDR Report Key: 7330415
• Date Received: 2018-03-09
• Date of Report: 2018-03-08
• Date of Event: 2018-02-22
• Date Added to Maude: 2018-03-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: 0

Device Details

• Brand Name: EASY GO VAC ASPIRATOR
• Generic Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Product Code: BTA
• Date Received: 2018-03-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PRECISION MEDICAL
• Manufacturer Address: NORTHHAMPTON PA 18067 US 18067

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-03-09