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); Device Emits Odor (1425); Electrical Shorting (2926)

Patient Problem No Information (3190)

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

Complaint was received on (b)(6) 2018 stating "after final visual inspection of the care e vacs a total of three units all have discoloration to the casing, and smell as if the unit has been shorted out.Upon return to (b)(6) on (b)(6) 2018 and repair center evaluation on july 24, 2018 it was noted "due to extent of damage, unit is beyond economical repair".Further evaluation was performed by engineering which determined that a short occured when battery terminals suspectedly came into contact with pump.

• 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 ; 8478556318
• MDR Report Key: 7778884
• MDR Text Key: 117300692
• Report Number: 1419185-2018-00006
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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: CEV318020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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