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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP MCH-1000(M)

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CARDIOQUIP LLC CARDIOQUIP MCH-1000(M) Back to Search Results
Device Problems Crack (1135); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  Malfunction  
Manufacturer Narrative

Upon inspection of the suspect device, it was found that the heating element failed, started overheating, and melted the adjacent pvc, resulting in the "smell of smoke" that the customer experienced. Through further investigation, it was determined that the heating element failed due to a degradation in the material, causing the heating element to not perform according to specifications.

 
Event Description

Customer reports that the unit started smelling like smoke while plugged into a power strip and during use on a patient. They also report that the unit will no longer cool.

 
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Brand NameCARDIOQUIP
Type of DeviceMCH-1000(M)
Manufacturer (Section D)
CARDIOQUIP LLC
8422 calibration ct
college station, tx
Manufacturer (Section G)
CARDIOQUIP
8422 calibration ct
college station, tx
Manufacturer Contact
melanie harry
8422 calibration ct
college station, tx 
6910202
MDR Report Key10287191
MDR Text Key202555182
Report Number3007899424-2020-00005
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Repair
Type of Report Initial
Report Date 07/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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