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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVEL 1; WARMER, THERMAL, INFUSION FLUID
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LEVEL 1; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number 7204012
Device Problems Display Difficult to Read (1181); Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2021
Event Type  malfunction  
Event Description
During the commissioning process for a new level 1 h-1025 fast flow infuser; it was noted that the pressure chamber gauge was showing the incorrect pressure.No patient involvement.
 
Manufacturer Narrative
Other text: information received a smiths medical fluid warming|level 1 trauma fast flow accessories complaint of the pressure chamber gauge was showing incorrect pressure was duplicated in testing.The physical condition of device revealed chamber secure clamp together with screws were missing seen in photos.The pressure chamber was replaced.
 
Event Description
Device evaluation completed and summary in h 10.
 
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Brand Name
LEVEL 1
Type of Device
WARMER, THERMAL, INFUSION FLUID
MDR Report Key11611916
MDR Text Key243911287
Report Number3012307300-2021-02824
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number7204012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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