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: HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING
  • 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
 

HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Catalog Number 1059
Device Problem Inflation Problem (1310)
Patient Problem No Patient Involvement (2645)
Event Date 10/12/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "during test before use, the reservoir bag was not inflated properly.He/she suspected air was leaking somewhere, so that used a new unit instead." no patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was then performed and the sample was placed on a nebulizer compressor and tested.During this time no issues were detected on this sample that can lead to the issue reported.Air was flowing properly.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.
 
Event Description
The complaint is reported as: "during test before use, the reservoir bag was not inflated properly.He/she suspected air was leaking somewhere, so that used a new unit instead." no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT
Type of Device
MASK, OXYGEN, NON-REBREATHING
MDR Report Key10773293
MDR Text Key214595279
Report Number3004365956-2020-00212
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1059
Device Lot Number74B2000979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-