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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K Back to Search Results
Model Number 16422
Device Problem Alarm Not Visible (1022)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2014
Event Type  malfunction  
Event Description
The service repair tech (srt) reported that during routine testing of the device at the service ctr, the light bulb for the alternating current (a/c) green light was burnt out.There was no patient involvement.
 
Manufacturer Narrative
The srt replaced the ddp led bulb.The unit operated to manufacturer specifications and was returned to clinical use.If additional info 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 PERFUSION SYSTEM 8000
Type of Device
8K
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 Key4366119
MDR Text Key18539762
Report Number1828100-2014-01134
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915183
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 12/11/2014
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 Number16422
Device Catalogue Number16422
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2001
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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