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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL LIMITED GUERNSEY CLEAR-THERM 3 HMEF; FILTER, BACTERIAL, BREATHING-CIRCUIT
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INTERSURGICAL LIMITED GUERNSEY CLEAR-THERM 3 HMEF; FILTER, BACTERIAL, BREATHING-CIRCUIT Back to Search Results
Model Number 1541000
Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 10/04/2019
Event Type  Injury  
Manufacturer Narrative
During use, the filter was used on the patient side of nebulization.This would have saturated the filters with the nebulized drug and increased the resistance to flow.Ifu states avoid use between the patient and a source of nebulised drugs.Monitor the hmef throughout use and replace if increased resistance or contamination occurs.A record review was completed for lot 2191371 no other complaints of this nature.
 
Event Description
Blocking of filter causing issues with patient ventilation.Reports of white foam oozing from filter when removed.Once identified filter removed.
 
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Brand Name
CLEAR-THERM 3 HMEF
Type of Device
FILTER, BACTERIAL, BREATHING-CIRCUIT
Manufacturer (Section D)
INTERSURGICAL LIMITED GUERNSEY
circuit house, pitronnerie rd
st. peter port, guernsey channel islands GY12R L
UK  GY12RL
Manufacturer Contact
ivan seniut
arnioniu 60/28-1
pabrade, vilniaus apskritis, lt-4710 
LH  
MDR Report Key9292786
MDR Text Key165948658
Report Number1319447-2019-00002
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K024270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1541000
Device Lot Number2191371
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Device Age1 YR
Event Location Hospital
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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