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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HELMER, INC. I.SERIES; REFRIGERATOR, FREEZER, BLOOD STORAGE
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HELMER, INC. I.SERIES; REFRIGERATOR, FREEZER, BLOOD STORAGE Back to Search Results
Model Number IB245
Device Problems Improper or Incorrect Procedure or Method (2017); Environmental Compatibility Problem (2929)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2019
Event Type  malfunction  
Event Description
Biomed completed a pm on blood bank refrigerator.Then, could not get the compressor to come back on.Temperature rose to above 6 degrees centigrade.The blood inventory was transferred to our backup blood bank refrigerator.Lab determined that biomed had changed a set point that should not have been changed, causing the compressor to turn off.Lab changed the set point back to correct setting and the refrigerator started cooling again.Temperature within normal range for below 6 degrees centigrade.After several hours of monitoring the temperature, the staff moved the blood bank inventory back to the main blood bank refrigerator described in this event.Biomed cleared to be placed back in service.
 
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Brand Name
I.SERIES
Type of Device
REFRIGERATOR, FREEZER, BLOOD STORAGE
Manufacturer (Section D)
HELMER, INC.
14400 bergen blvd
noblesville IN 46060
MDR Report Key8739112
MDR Text Key149345426
Report Number8739112
Device Sequence Number1
Product Code KSE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIB245
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2019
Event Location Hospital
Date Report to Manufacturer06/27/2019
Type of Device Usage N
Patient Sequence Number1
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