• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 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
 

PORTEX; GENERAL ANESTHESIA CIRCUITS Back to Search Results
Catalog Number C45101344-NLJ
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
Event Type  malfunction  
Event Description
Information was received that during a pre-use air leak check, leakage in the product was detected.No patient injury.
 
Manufacturer Narrative
One breathing circuit device was received for evaluation.Visual inspection of the device found breathing bag to have a pinhole.The device underwent functional testing; the circuit passed leak testing.Additionally, a random sample of 32 bags were reviewed during the complete process, the units were visually inspected to verify that all bags were free of damage (tears, scuffs, pinch marks, contamination, etc.), and it was seen that the bags were without damage.No discrepancies were found.Visual inspection confirmed a pinhole, and the problem source has been determined to be manufacturing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX
Type of Device
GENERAL ANESTHESIA CIRCUITS
MDR Report Key10477095
MDR Text Key205119997
Report Number3012307300-2020-08882
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/09/2020
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 No Information
Device Catalogue NumberC45101344-NLJ
Device Lot Number3923196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received09/01/2020
Supplement Dates Manufacturer Received09/22/2020
Supplement Dates FDA Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-