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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGIQUEST, INC SURGIQUEST AIRSEAL; INSUFFLATOR
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SURGIQUEST, INC SURGIQUEST AIRSEAL; INSUFFLATOR Back to Search Results
Model Number AS-IFS1
Device Problem Insufficient Information (3190)
Patient Problem Hypoxia (1918)
Event Type  Injury  
Manufacturer Narrative
Good faith efforts to obtain additional information from the facility have not been successful.If additional information is becomes available, a follow-up report will be made.The company continues to monitor the clinical use of airseal ifs and works diligently to ensure product safety.Device is still in use at the facility.
 
Event Description
On (b)(6) 2015 , surgiquest inc.Became aware of a report of a patient suffering "unexplained hypoxemia , post surgery and had to go to the icu.No additional information was received.
 
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Brand Name
SURGIQUEST AIRSEAL
Type of Device
INSUFFLATOR
Manufacturer (Section D)
SURGIQUEST, INC
488 wheelers farms road
milford CT 06461
Manufacturer Contact
ms calzetta
488 wheelers farms road
milford, CT 06461
2037992400
MDR Report Key5532048
MDR Text Key41367840
Report Number3006217371-2016-00008
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberAS-IFS1
Device Catalogue NumberAS-IFS1
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/26/2016
Initial Date FDA Received03/29/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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