MAUDE Adverse Event Report: ALLIED HEATLHCARE PRODUCT INC. GOMCO 180; G180

Model Number	G180
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The company sent this description of the problem: 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/ selftapping 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.

• Brand Name: GOMCO 180
• Common Device Name: G180
• Manufacturer (Section D): ALLIED HEATLHCARE PRODUCT INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 16678661
• Report Number: 1924066-2023-00001
• Device Sequence Number: 5821432
• Product Code: JCX
• UDI-Device Identifier: 00026072011294
• UDI-Public: 00026072011294
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G180
• Device Catalogue Number: G180
• Device Lot Number: 2023-01-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown