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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 100 MONITOR
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 100 MONITOR Back to Search Results
Model Number 100
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The service repair technician (srt) reported that during routine testing of the device at the service center, the battery was cracked in the blood parameter monitor (bpm).There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.The battery is damaged and has leaked internal fluid into the unit.The product has been moved to the service department for disposition and will be scrapped.If additional information become 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 CDI 100 MONITOR
Type of Device
CDI 100
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 Key4597349
MDR Text Key5628416
Report Number1828100-2015-00147
Device Sequence Number1
Product Code DTY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902654
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 02/10/2015
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 Number100
Device Catalogue Number100
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/26/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/10/2015
Initial Date FDA Received03/05/2015
Was Device Evaluated by Manufacturer? Yes
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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