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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 Problem Excessive Heating (4030)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2020
Event Type  Malfunction  
Manufacturer Narrative

Investigation is pending. Suspect device has yet to be made available to cardioquip for evaluation.

 
Event Description

Customer reports that the unit is giving high temp alarms after running for 5-7 hours while on a patient, with users reporting that they've seen the delivery temperature spike to over 55 degrees at one point.

 
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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 LLC
8422 calibration ct
college station, tx
Manufacturer Contact
melanie harry
8422 calibration ct
college station, tx 
6910202
MDR Report Key10291910
MDR Text Key201730300
Report Number3007899424-2020-00006
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,Followup,Followup
Report Date 03/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/12/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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