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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL INCORPORATED INTERSURGICAL; HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL CHAMBER
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INTERSURGICAL INCORPORATED INTERSURGICAL; HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL CHAMBER Back to Search Results
Catalog Number 2026031
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2016
Event Type  malfunction  
Event Description
Respiratory therapist observed that the heater probe on the patient's ventilator was not holding a tight seal resulting in a major leak.The respiratory therapist promptly took appropriate intervention and there was no harm to the patient.
 
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Brand Name
INTERSURGICAL
Type of Device
HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL CHAMBER
Manufacturer (Section D)
INTERSURGICAL INCORPORATED
6757 kinne street
east syracuse NY 13057
Manufacturer Contact
ivan seniut
arnioniu, 60/28-1
lt-18170
pabrade, 
LH  
38766609
MDR Report Key5577442
MDR Text Key43296860
Report Number1319447-2016-70007
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/17/2016,04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2026031
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2016
Distributor Facility Aware Date04/12/2016
Event Location Hospital
Date Report to Manufacturer04/13/2016
Date Manufacturer Received04/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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