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

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER & VENTILATOR, EMERGENCY, MANUAL

  • 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
 

TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER & VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Catalog Number 5367
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint reported as: "duck bill valve would not open and therefore did not function properly. Manual ventilation could not be given. " no patient harm reported. Additional information was requested, but was not available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER &
Type of DeviceVENTILATOR, EMERGENCY, MANUAL
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9578004
MDR Text Key191028992
Report Number3011137372-2020-00015
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5367
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
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

-
-