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MAUDE Adverse Event Report:; BREATHING CIRCUIT
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; BREATHING CIRCUIT
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Device Problem
No Fail-Safe Mechanism (2990)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date
01/11/2015
Event Type
malfunction
Event Description
Potential for harm: cardiac/respiratory arrest, rt does not have a pediatric ventilation circuit.Potentially extremely dangerous.
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Submit an Adverse Event Report
Type of Device
BREATHING CIRCUIT
MDR Report Key
6332563
MDR Text Key
67565193
Report Number
6332563
Device Sequence Number
1
Product Code
CAG
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
User Facility
Reporter Occupation
Other
Type of Report
Initial
Report Date
09/15/2015,09/18/2015
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this a Product Problem Report?
Yes
Device Operator
No Information
Was Device Available for Evaluation?
No
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
09/15/2015
Event Location
Hospital
Date Report to Manufacturer
09/15/2015
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
02/15/2017
Was Device Evaluated by Manufacturer?
Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device?
Yes
Type of Device Usage
N
Patient Sequence Number
1
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