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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM; HEART-LUNG,CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM; HEART-LUNG,CARDIOPULMONARY BYPASS Back to Search Results
Model Number 70104.8012
Device Problem Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2012
Event Type  malfunction  
Event Description
On (b)(6) 2012, an out of box failure occurred for cardiohelp (serial number (b)(4)).The cardiohelp's external temperature connector gave inaccurate numbers.Reference: complaint (b)(4).
 
Manufacturer Narrative
(b)(4).On (b)(6) 2012, correspondence was received from the sales and service unit (ssu) that a different cable is being used and the unit works as intended.Reference: complaint (b)(4).
 
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Brand Name
CARDIOHELP SYSTEM
Type of Device
HEART-LUNG,CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
kehler strasse 31
rastatt, 7643 7
GM  76437
Manufacturer (Section G)
MAQUET CARDIOPULMONARY AG
kehler strasse 31
rastatt, 7643 7
GM   76437
Manufacturer Contact
tina evancho
maquet medical system, usa
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4279842
MDR Text Key20074071
Report Number8010762-2014-00666
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number70104.8012
Device Catalogue Number70104.8012
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/27/2012
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer11/27/2012
Initial Date Manufacturer Received 11/27/2012
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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