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

MAUDE Adverse Event Report: 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
 

CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
The elbow connector was returned and it was found to be damaged and cracked. The reported issue was able to be confirmed. It is probable that this event caused a crack due to a physical impact applied to the elbow connector. However, it was not possible to identify the time when the problem occurred, and it was not possible to identify the root cause of the problem. (b)(6).
 
Event Description
Information was received indicating that a smiths medical breathing circuit was found to be damaged at the elbow connector. This was found during a pre-use check and there were no reported adverse events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
MDR Report Key12239995
MDR Text Key263888996
Report Number3012307300-2021-07734
Device Sequence Number1
Product Code CAI
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
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-