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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE) Back to Search Results
Model Number 802111
Device Problem Out-Of-Box Failure (2311)
Patient Problem Not Applicable (3189)
Event Date 06/16/2014
Event Type  malfunction  
Event Description
Upon receipt of the level module, the field service representative (fsr) reported when he installed the level module assembly, it caused all other modules to reboot.This considered an "out of box" failure.There was no patient involvement.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.This complaint is related to mdr 1828100-2014-00553 and 1828100-2014-00578.
 
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Brand Name
TERUMO ADVANCED PERFUSION SYSTEM 1
Type of Device
APS 1 (HEART LUNG CONSOLE)
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson rd.
ann arbor, MI 48103
7346634145
MDR Report Key4002340
MDR Text Key4692392
Report Number1828100-2014-00594
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/16/2014
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 Number802111
Device Catalogue Number802111
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/23/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/16/2014
Initial Date FDA Received07/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2014
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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