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

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 was initiated for correction of other potentially affected devices.
Event or Problem Description
Device was subject to fca 1419185-7/24/18-001-c, and user facility noticed burnt battery wires.Upon device return to manufacturer on (b)(6) 2018 it was noted that wires were in fact burned.The root cause was found to be the same as reason for field corrective action initiation.

• 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 Key: 8100343
• Report Number: 1419185-2018-00010
• Device Sequence Number: 13876594
• Product Code: BTA
• UDI-Device Identifier: 08688250002436
• UDI-Public: (01)08688250002436
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/24/2018

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: CEB171034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1