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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS; ANESTHESIA CONDUCTION KIT
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NULL BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 3907300
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2020
Event Type  malfunction  
Event Description
It was reported that during pre-use check, air leak test was not successful.No patient injury was reported.
 
Manufacturer Narrative
Catalog number is unknown.Udi information is unknown operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual evaluation of product resulted in no detectable discrepancies.A leak test was performed, and was successful.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
BREATHING PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15426995
MDR Text Key305897091
Report Number3012307300-2022-19246
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number3907300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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