MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. OPTIVAC AC/DC PORTABLE SUCTION UNIT GOMCO; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number G180

Device Problems Component Incompatible (1108); Mechanical Problem (1384); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Staff were unable to turn off our new gomco g180 portable aspirators.Upon investigation, biomed staff that the entire new fleet (~30) were all defective.The circuit boards do not sit correctly on the face plates, causing the on and off buttons not to work easily.Our supervisory biomedical equipment support specialist did a deep dive and found that there were 2 screws of one type/ self-tapping and a third of a different type/ standard threaded screw.One screw was stripped and the other wasn't tight enough to keep board flush.Ref report: mw5115618.

• Brand Name: OPTIVAC AC/DC PORTABLE SUCTION UNIT GOMCO
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; st. louis MO 63110
• MDR Report Key: 16514983
• MDR Text Key: 311128728
• Report Number: MW5115619
• 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: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G180
• Device Catalogue Number: 241524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1