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U.S. Department of Health and Human Services

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

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ALLIED HEALTHCARE PRODUCTS, INC. GOMCO 4005 SUCTION PUMP Back to Search Results
Model Number 01-12-4005
Device Problem Failure to Obtain Sample
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.

 
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Brand NameGOMCO 4005 SUCTION PUMP
Type of DeviceSUCTION 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 Key5224643
Report Number1924066-2015-00004
Device Sequence Number1
Product CodeJCX
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
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number01-12-4005
Device Catalogue Number01-12-4005
Device LOT Number20060606048
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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