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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL INCORPORATED INTERSURGICAL; DUAL LIMB HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL HUMIDIFCATION CHAMBER
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INTERSURGICAL INCORPORATED INTERSURGICAL; DUAL LIMB HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL HUMIDIFCATION CHAMBER Back to Search Results
Catalog Number 2026031
Device Problem Disconnection (1171)
Patient Problem No Code Available (3191)
Event Date 03/09/2016
Event Type  malfunction  
Event Description
It is reported that the respiratory therapist observed that the heater probe became disconnected (popped out) from the heater pot.It is reported that the patient did have decreased respiratory status during this time.It is reported that medications were administered to the patient and the probe was re-inserted.It is also reported that appropriate interventions were taken by the therapist.
 
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Brand Name
INTERSURGICAL
Type of Device
DUAL LIMB HEATED WIRE BREATHING CIRCUIT WITH AUTO-FILL HUMIDIFCATION 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 Key5615838
MDR Text Key44619644
Report Number1319447-2016-70016
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 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number2026031
Is the Reporter a Health Professional? No
Distributor Facility Aware Date04/27/2016
Event Location Hospital
Date Report to Manufacturer04/28/2016
Date Manufacturer Received04/28/2016
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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