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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO CENTRIFUGAL SYSTEM
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TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO CENTRIFUGAL SYSTEM Back to Search Results
Model Number 9490
Device Problem Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2013
Event Type  malfunction  
Event Description
The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the battery back-up unit was not charging on the centrifugal system.Since the event occurred during preventative maintenance, there was no patient involvement.
 
Manufacturer Narrative
The field service representative (fsr) replaced a fuse to repair the centrifugal system.He is not returning the suspect fuse as it was disposed of.The unit operated to manufacturer specifications and was returned to clinical use.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
TERUMO CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson rd.
ann arbor, MI 48103
7346634145
MDR Report Key3647641
MDR Text Key4195308
Report Number1828100-2013-01167
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/17/2013
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 Number9490
Device Catalogue Number9490
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/17/2013
Initial Date FDA Received01/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2001
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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