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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KING SYSTEMS ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT
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KING SYSTEMS ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT Back to Search Results
Model Number KN6903B-6121Z
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Low Oxygen Saturation (2477)
Date of Event 07/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
 
Event or Problem Description
Per complainant: patient desatted (desaturated) in the cv or during the case.The patient was reported to be very sick patient; this occurred 8-12 hours into the case when the patient was being moved/turned over.Anesthesia was able to take a new circuit and switch out the hme-f and replace it with a new one with no problem.Patient is doing fine.
 
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Brand Name
ADULT ULTRA FLEX ANESTHESIA BREATHING CIRCUIT
Common Device Name
ANESTHESIA BREATHING CIRCUIT
Manufacturer (Section D)
KING SYSTEMS
15011 herriman blvd.
noblesville IN 46060
MDR Report Key7771108
Report Number1824226-2018-00002
Device Sequence Number19121623
Product Code CAI
UDI-Device Identifier00612649204673
UDI-Public(01)00612649204673
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberKN6903B-6121Z
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/10/2018
Initial Report FDA Received Date08/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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