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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Portex; BREATHING-CIRCUIT
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Portex; BREATHING-CIRCUIT Back to Search Results
Model Number C1034J
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that during the use of the product, it got easily disconnected from the anesthesia device.No patient injury.
 
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Brand Name
Portex
Type of Device
BREATHING-CIRCUIT
MDR Report Key12752514
MDR Text Key280160369
Report Number3012307300-2021-10726
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC1034J
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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