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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM
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MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM Back to Search Results
Catalog Number 70104.8803
Device Problems Failure to Recalibrate (1517); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/14/2011
Event Type  Injury  
Event Description
It was reported that the vsat (venous oxygen saturation) was low and unable to recalibrate while o a pt.When a calibration was completed the hct levels were high and compared to the normal readings the user was expecting.As a precaution the venous probe and cable were replaced.According to the perfusionist at the account, they (the low saturation values) were verified with lab results.A service technician tested the probe to factory specifications.The venous probe reported was in use with cardiohelp-i console model number 70104.8012, serial number (b)(4).Both the probe and console are components of the cardiohelp system cleared under 510(k) #k102726.(b)(4).
 
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Brand Name
CARDIOHELP SYSTEM
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key4544302
MDR Text Key16078008
Report Number3008355164-2015-00027
Device Sequence Number1
Product Code DTQ
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 02/20/2015,12/28/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number70104.8803
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/28/2011
Event Location Hospital
Date Report to Manufacturer01/03/2012
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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