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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 801763
Device Problem Failure to Run on Battery (1466)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2014
Event Type  malfunction  
Event Description
It was reported that during the use of the device for a non-clinical activity, the perfusion system did not boot up on battery.Issue occurred when the perfusionist (ccp) tried to power up the system to change the time of day.There was no case scheduled, therefore no delay of case.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 Key4307578
MDR Text Key5270912
Report Number1828100-2014-01004
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2014
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 Health Professional
Device Model Number801763
Device Catalogue Number801763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received11/25/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2006
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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