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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHIO MEDICAL LLC CARE-E-VAC 3; PORTABLE SUCTION DEVICE
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OHIO MEDICAL LLC CARE-E-VAC 3; PORTABLE SUCTION DEVICE Back to Search Results
Model Number 758000
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Field correction 1419185-7/24/18-001-c has been initiated for correction of other potentially affected devices.
 
Event or Problem Description
On (b)(6) 2018 a complaint was received for the care-e-vac 3 device in which the customer stated "one of the units looks damaged/ used".The device was returned on 06/21/2018 and a replacement device was sent to the customer.On (b)(6) 2018 there was an occurrence in house during assembly of the care-e-vac 3 device in which same time of effect occurred (melted wires leading from battery to the pc board).Ship hold was initiated immediately and investigation began looking further into the cause of the melted wires.
 
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Brand Name
CARE-E-VAC 3
Common Device Name
PORTABLE SUCTION DEVICE
Manufacturer (Section D)
OHIO MEDICAL LLC
1111 lakeside dr
gurnee IL 60031
MDR Report Key7771116
Report Number1419185-2018-00005
Device Sequence Number13918567
Product Code BTA
UDI-Device Identifier08688250002436
UDI-Public(01)08688250002436
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
K062610
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Remedial Action Other,Replace
Type of Report Initial
Report Date (Section B) 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number758000
Device Catalogue Number758000
Device Lot NumberCEV318015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/22/2018
Initial Report FDA Received Date08/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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