Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE Back to Search Results
Model Number C49101320J
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, leakage of air from the product was detected.No patient injury.
 
Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review was done, no issues related to the original complaint were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
Manufacturer (Section G)
NULL
MDR Report Key12975777
MDR Text Key282046812
Report Number3012307300-2021-12598
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 Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/22/2022
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
Device Expiration Date04/15/2024
Device Model NumberC49101320J
Device Catalogue NumberC49101320J
Device Lot Number4124695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/11/2021
Initial Date FDA Received12/10/2021
Supplement Dates Manufacturer Received01/24/2022
Supplement Dates FDA Received02/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-