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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX BREATHING-CIRCUIT

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NULL PORTEX BREATHING-CIRCUIT Back to Search Results
Model Number CA13K0/400/000JP
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
One unit was returned for investigation. Upon physical inspection, it was found that the complained issue could not be duplicated. (b)(4) owns all complaint handling, complaint investigations and reporting responsibilities. We issued complaint notification to the supplier "(b)(4)", requesting them to investigate the event.
 
Event Description
It was reported that during the pre-use check, the hme filter got detached with just a little force. No patient injury.
 
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Brand NamePORTEX
Type of DeviceBREATHING-CIRCUIT
Manufacturer (Section G)
NULL
MDR Report Key13170018
MDR Text Key283260738
Report Number3012307300-2022-00130
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 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
Device Model NumberCA13K0/400/000JP
Device Catalogue NumberCA13K0/400/000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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