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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 (EPGS)

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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (EPGS) Back to Search Results
Model Number 801188
Device Problem Device Inoperable (1663)
Patient Problem Not Applicable (3189)
Event Date 05/14/2014
Event Type  malfunction  
Event Description
The field service representative (fsr) reported that during field service installation of the device, the electronic patient gas system (epgs) failed as the unit would not power up.The light emitting diode (led) on front of the epgs did not light up and then when fsr went into the service menu, it did not show up.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 (EPGS)
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 Key3998748
MDR Text Key4776887
Report Number1828100-2014-00501
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 Not Applicable
Type of Report Initial
Report Date 05/14/2014
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 Number801188
Device Catalogue Number801188
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/20/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/14/2014
Initial Date FDA Received06/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2007
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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