• 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

  • 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 Back to Search Results
Model Number C37091326-NLJ
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, the breathing bag was found damaged. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORTEX GENERAL ANESTHESIA CIRCUITS
Manufacturer (Section G)
NULL
MDR Report Key13950305
MDR Text Key294053841
Report Number3012307300-2022-05504
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC37091326-NLJ
Device Catalogue NumberC37091326-NLJ
Device Lot Number4190260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2022
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-