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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. DUAL COOLER/HEATER; SARMS DUAL COOLER/HEATER
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TERUMO CARDIOVASCULAR SYSTEMS CORP. DUAL COOLER/HEATER; SARMS DUAL COOLER/HEATER Back to Search Results
Model Number 11160
Device Problem Leak/Splash (1354)
Patient Problem Not Applicable (3189)
Event Date 06/04/2014
Event Type  malfunction  
Event Description
It was reported that during the use of the device for a non-clinical activity, the customer was putting the cooler heater unit back into service.When they filled with water, the unit started leaking.This cooler heater unit has not been used in five years.There was no pt involvement.
 
Manufacturer Narrative
The customer has decided not to repair the cooler heater unit.The unit will be retired.If add'l 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
DUAL COOLER/HEATER
Type of Device
SARMS DUAL COOLER/HEATER
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 Key3966277
MDR Text Key17389946
Report Number1828100-2014-00527
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11160
Device Catalogue Number11160
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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