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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS CAI

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NULL PORTEX GENERAL ANESTHESIA CIRCUITS CAI Back to Search Results
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, a pinhole in the breathing bag was found. When the customer attempted to detach the breathing bag from the connector, the bag got torn. No patient injury was reported.
 
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Brand NamePORTEX GENERAL ANESTHESIA CIRCUITS
Type of DeviceCAI
Manufacturer (Section G)
NULL
MDR Report Key13169783
MDR Text Key286859729
Report Number3012307300-2022-00122
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2021
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

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