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

Model Number 758000

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Melted (1385); Nonstandard Device (1420); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

Field correction 1419185-7/24/18-001-c has been initiated for correction of other potentially affected devices.

Event 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
• Type of Device: PORTABLE SUCTION DEVICE
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031 2489
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031 ; 8478556318
• MDR Report Key: 7765710
• MDR Text Key: 117003167
• Report Number: 1419185-2018-00002
• Device Sequence Number: 1
• Product Code: BTA
• UDI-Device Identifier: 08688250002436
• UDI-Public: (01)08688250002436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1