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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUITS; ANESTHESIA BREATHING CIRCUIT KIT
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NULL PORTEX ANESTHESIA BREATHING CIRCUITS; ANESTHESIA BREATHING CIRCUIT KIT Back to Search Results
Model Number C37101329-NLJ
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  malfunction  
Event Description
It was reported that during air leak check, leakage was found in the anesthesia circuit.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 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.The circuit did not pass the leak test.The most probable cause is that the product became damaged after it left the facility].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 BREATHING CIRCUIT KIT
Manufacturer (Section G)
NULL
MDR Report Key15445242
MDR Text Key305875486
Report Number3012307300-2022-19596
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberC37101329-NLJ
Device Lot Number3986635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2022
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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