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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1 Back to Search Results
Model Number 816300
Device Problems Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Per the perfusionist, the problem has been resolved and no further service is needed.
 
Event Description
It was reported that the central control monitor (ccm) was frozen.No other details regarding the nature of this event were provided.
 
Manufacturer Narrative
The reported complaint could not be verified.The request for service was cancelled, and the part was not returned to the manufacturer after multiple diligence attempts, therefore no evaluation could be done.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand Name
ADVANCED PERFUSION SYSTEM 1
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key10254430
MDR Text Key199870419
Report Number1828100-2020-00257
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K172220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number816300
Device Catalogue Number816300
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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