MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GOMCO; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number G180

Device Problem Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

Dr.Wanted to suction the patient.Suction machine was tested at crash cart and it worked.In room, what caused this, but when turned on the lid exploded on the canister.Machine was taken out of the room.

• Brand Name: GOMCO
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; saint louis; MO 63110
• MDR Report Key: 16831539
• MDR Text Key: 314176710
• Report Number: 16831539
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G180
• Device Catalogue Number: G180
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Date Report to Manufacturer: 04/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1