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 NumberMW5075796
MDR Report Key7330415
Date Received2018-03-09
Date of Report2018-03-08
Date of Event2018-02-22
Date Added to Maude2018-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEASY GO VAC ASPIRATOR
Generic NamePUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Product CodeBTA
Date Received2018-03-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPRECISION MEDICAL
Manufacturer AddressNORTHHAMPTON PA 18067 US 18067


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-09

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