MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GOMCO 4005 SUCTION PUMP

Model Number 01-12-4005

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

Unit involved and/or switch is not being returned for evaluation.Serial number (b)(4) indicated the unit was manufactured in june, 2006.Which makes the unit 9 years old.The rocker switch involved is underwriters laboratories listed.Ul does an endurance test which requires 6,000 operations at full load with no failures.(b)(4), the maker of the switch, state the life expectancy normally is quite a bit more, 10,000 to 50,000 cycles.We do not know if the switch was damaged by handling, contamination, and/or cleaning solutions during it's 9 years of service.These rocker switches should be operated using a finger or thumb.They should not be operated using pens, pencils, or other hospital instruments.

Event Description

It was reported that while attempting to turn off suction machine, the switch would not move.Biomed was notified, machine was evaluated and switch was replaced.Passed functional test and returned to service.No patient information available.

• Brand Name: GOMCO 4005 SUCTION PUMP
• Type of Device: SUCTION PUMP
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; st. louis MO 63110
• Manufacturer Contact: wayne karcher ; 1720 sublette ave.; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 5224643
• MDR Text Key: 31462777
• Report Number: 1924066-2015-00004
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-12-4005
• Device Catalogue Number: 01-12-4005
• Device Lot Number: 20060606048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1