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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
Device Problem Insufficient Information (3190)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/10/2018
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event 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 NameADULT ULTRA FLEX ANESTHESIA 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 Key7771108
MDR Text Key116711067
Report Number1824226-2018-00002
Device Sequence Number1
Product Code CAI
UDI-Device Identifier00612649204673
UDI-Public(01)00612649204673
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 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKN6903B-6121Z
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/09/2018 Patient Sequence Number: 1
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