MAUDE Adverse Event Report: OHIO MEDICAL, LLC CARE-E-VAC 3; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number CARE-E-VAC 3

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Fainting (1847)

Event Date 11/17/2015

Event Type  malfunction  

Event Description

A patient collapsed during therapy.As the patient was being resuscitated, there were concerns that the portable suction unit was not working properly.The white tops on the suction canister were cracking.The wrong lids were being used on the canisters.

• Brand Name: CARE-E-VAC 3
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): OHIO MEDICAL, LLC; 1111 lakeside drive; gurnee IL 60031
• MDR Report Key: 6002600
• MDR Text Key: 56564508
• Report Number: 6002600
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARE-E-VAC 3
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 106