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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUITS; ANESTHESIA CONDUCTION KIT
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NULL PORTEX ANESTHESIA BREATHING CIRCUITS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number CA13B0/400/000JP
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
It was reported that the gas sampling port was damaged.No patient injury was reported.
 
Manufacturer Narrative
Manufacturing site address is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Premarket (510k) number is unknown.A product sample was received for evaluation.Visual and functional testing were performed.The reported event was confirmed.The root cause may be due to manufacturing.A secondary evaluation was performed confirming the supplied item as faulty.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUITS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15418430
MDR Text Key305363449
Report Number3012307300-2022-19144
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCA13B0/400/000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
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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