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

Model Number 758000

Device Problems Thermal Decomposition of Device (1071); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Device was subject to fca 1419185-7/24/18-001-c, and user facility noticed burnt battery wires.Upon return to manufacturer on (b)(6) 2018 in was confirmed that wires were in fact burned.The root cause was found to be the same reason for field corrective action initiation.

• Brand Name: CARE-E-VAC 3
• Type of Device: PORTABLE SUCTION DEVICE
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer (Section G): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• Manufacturer Contact: jessica barrile ; 1111 lakeside dr; gurnee, IL 60031
• MDR Report Key: 8100344
• MDR Text Key: 128586536
• Report Number: 1419185-2018-00011
• 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: Recall
• Type of Report: Initial
• Report Date: 11/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2018
• 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: CEB171034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1