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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 801763
Device Problems Out-Of-Box Failure (2311); Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Per fsr this unit is not used clinically but for classroom training only.The fsr charged the batteries over the weekend.The unit operated to the manufacturer¿s specifications.
 
Event Description
The field service representative (fsr) reported that during field service installation, the batteries on the unit were completely dead.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.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 Key7601877
MDR Text Key111163145
Report Number1828100-2018-00313
Device Sequence Number1
Product Code DTQ
UDI-Device Identifier00886799000656
UDI-Public(01)00886799000656(11)180319
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
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number801763
Device Catalogue Number801763
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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