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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP 1
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MAQUET CARDIOPULMONARY AG CARDIOHELP 1 Back to Search Results
Catalog Number 701048012
Device Problems False Alarm (1013); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2012
Event Type  Injury  
Event Description
Customer stated the cardiohelp would display lpm low flow and rpm read zero while on a patient/ perfusionist tried to re-initialize the cardiohelp by increasing the flow and restarting the flow.System would run for a few seconds and go back to low flow alarms.Alarms would still alarm and no intervention would clear the system to allow a restart.User manually turned off systems and rebooted the same problem occurred.New system was put on patient and with no adverse effect.Arrived on (b)(4) 2012 tested system to factory specs tested ok.No problem found.(b)(4).
 
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Brand Name
CARDIOHELP 1
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key4365264
MDR Text Key5266955
Report Number3008355164-2014-00361
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/16/2014,04/09/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number701048012
Device Lot Number90410231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/09/2012
Event Location Hospital
Date Report to Manufacturer04/09/2012
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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