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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BREATHING PORTEX GENERAL ANESTHESIA SODASORB CO2 A; ABSORBENT, CARBON-DIOXIDE
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NULL BREATHING PORTEX GENERAL ANESTHESIA SODASORB CO2 A; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
Catalog number is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Initial reporter also sent report to fda is unknown.No information has been provided to date.Premarket (510k) number is unknown.Manufacturing site address is unknown.A device history record (dhr) review was conducted by the supplier.No product sample was received; therefore, visual and functional testing could not be performed.The root cause of the reported issue has been determined by the supplier that the damage occurs during shipments of single cartons of pre-paks from the distributors to end user.(b)(4).
 
Event Description
It was reported that two cases of product were received damaged with solution leaking from container.No patient injury was reported.
 
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Brand Name
BREATHING PORTEX GENERAL ANESTHESIA SODASORB CO2 A
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section G)
NULL
MDR Report Key15476586
MDR Text Key306253853
Report Number3012307300-2022-18893
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2022
Initial Date FDA Received09/24/2022
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
Patient Sequence Number1
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