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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL FLEX2 BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT

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KING SYSTEMS UNIVERSAL FLEX2 BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT Back to Search Results
Model Number KNCF375-6121Z
Device Problem Material Separation (1562)
Patient Problem Low Oxygen Saturation (2477)
Event Date 05/05/2017
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
Patient's co2 began to rise after induction of anesthesia. Clinician began treatment protocol for malignant hyperthermia (mh). Patient's co2 did not respond adequately to mh protocol, so breathing circuit was removed and a bag-valve-mask was used to ventilate the patient at which time it was discovered that the inspiratory (inner) tube of the coaxial breathing circuit had detached from inner tube of the cuff. Patient's co2 levels improved and patient was transferred to the icu, and later transferred to another facility where she could be evaluated by a interventional radiologist for possible deep vein thrombosis in her arm as a result of the mh therapy.
 
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Brand NameUNIVERSAL FLEX2 BREATHING CIRCUIT
Type of DeviceANESTHESIA BREATHING CIRCUIT
Manufacturer (Section D)
KING SYSTEMS
15011 herriman blvd.
noblesville IN 46060
Manufacturer (Section G)
KING SYSTEMS
15011 herriman blvd.
noblesville IN 46060
Manufacturer Contact
wayne nethercutt
15011 herriman blvd.
noblesville, IN 46060
3177763175
MDR Report Key6590484
MDR Text Key76049617
Report Number1824226-2017-00003
Device Sequence Number1
Product Code CAI
UDI-Device Identifier00612649204840
UDI-Public(01)00612649204840
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/23/2019
Device Model NumberKNCF375-6121Z
Device Catalogue NumberKNCF375-6121Z
Device Lot Number1985606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2017 Patient Sequence Number: 1
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