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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL INCORPORATED INTERSURGICAL; AUTO FILL HUMIDIFICATION CHAMBER
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INTERSURGICAL INCORPORATED INTERSURGICAL; AUTO FILL HUMIDIFICATION CHAMBER Back to Search Results
Model Number 2310030
Device Problems Fail-Safe Design Failure (1222); Failure to Sense (1559); Overfill (2404)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It is reported that the humidification chambers are flooding the patient circuits and there are concerns for patient safety.It is reported that the chambers do not seem to be sensing when the water level has reached full and are therefore not stopping the flow of water into the chamber.No patient harm was reported or medical intervention required.
 
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Brand Name
INTERSURGICAL
Type of Device
AUTO FILL HUMIDIFICATION 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 Key5574834
MDR Text Key43038306
Report Number1319447-2016-70005
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 Health Professional
Type of Report Initial
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2310030
Device Catalogue Number2310030
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/16/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer03/21/2016
Date Manufacturer Received03/16/2016
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) Other;
Patient Age70 YR
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