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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIO COOLER HEATER

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CARDIOQUIP CARDIOQUIO COOLER HEATER Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Difficult or Delayed Activation (2577)
Patient Problem No Information (3190)
Event Type  No Answer Provided  
Event Description

The customer reported that the device powered on with a different startup screen that would not allow the unit to run without having a passcode entered. Because the customer was unable to guess the password, the perfusionists had to swap the unit with another one during "a very difficult time of initiating ecmo". The passcode screen appeared due to a recent pm performed by the manufacturer, in which a technician had placed the unit in test mode but did not exit the testing mode when they had completed the maintenance.

 
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Brand NameCARDIOQUIO
Type of DeviceCOOLER HEATER
Manufacturer (Section D)
CARDIOQUIP
MDR Report Key6386905
MDR Text Key69484034
Report NumberMW5068334
Device Sequence Number0
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

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