MAUDE Adverse Event Report: OHIO MEDICAL LLC CARE-E-VAC 3; PORTABLE SUCTION DEVICE

Model Number	758000
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2018
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 11/15/2017 a complaint was received for the care-e-vac 3 device in which the customer stated "out of box failure".Upon return to the manufacturer on 12/7/2017 the following was noted by the repair technician " note: this is not an out of box failure.Evidence of extensive use and seal broken indicating unit has been opened.Inspection in repair center shows this unit had liquid damage causing catastrophic electrical failure." pictures were provided that show melted wires from the device battery to the pc board.Device was retained by engineering.On (b)(6) 2018 there was an occurence in house during assembly of the care-e-vac 3 device in which same time of effect occured (melted wires leading from battery to the pc board).Ship hold was initiated immediately and investigation began looking further into the cause of the burning/ melted wires.This device was re-evaluated by engineering with comparison to failure which occured in house.Same effects of failure were observed.

• Brand Name: CARE-E-VAC 3
• Common Device Name: PORTABLE SUCTION DEVICE
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031 2489
• MDR Report Key: 7765710
• Report Number: 1419185-2018-00002
• Device Sequence Number: 19222488
• Product Code: BTA
• UDI-Device Identifier: 08688250002436
• UDI-Public: (01)08688250002436
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K062610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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 Number: 758000
• Device Catalogue Number: 758000
• Device Lot Number: CEB171029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1