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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 806455
Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2014
Event Type  malfunction  
Event Description
It was reported that during routine testing of the device at the user facility, the occluder would not close completely.There was an abnormal noise from occluder head during calibration.There was no patient involvement.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
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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 Key4349499
MDR Text Key19764192
Report Number1828100-2014-01064
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number806455
Device Catalogue Number806455
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/25/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2006
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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