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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG
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TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG Back to Search Results
Catalog Number 5346
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been returned to the manufacturer.However, the investigation of said device is still in progress at the time of this report.This report will be updated at the conclusion of the device evaluation.
 
Event Description
Customer complaint alleges "when this product connects reservoir valve assembly and intake valve housing assembly, the connected part is loose and easily dislodged." alleged defect reported as prior to patient use, during inspection/ functional testing.No report of patient harm.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.The dimensions of the fitting port were measured and were found to be within specification.The reservoir valve was completely assembled to the intake valve.The reservoir valve matched firmly with the intake valve.The sample was then functionally tested.No issues were found with the reservoir valve.Based on the investigation performed, the reported complaint of "loose connection with valve and housing" could not be confirmed.There were no issues found with the returned sample.
 
Event Description
Customer complaint alleges "when this product connects reservoir valve assembly and intake valve housing assembly, the connected part is loose and easily dislodged." alleged defect reported as prior to patient use, during inspection/ functional testing.No report of patient harm.
 
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Brand Name
HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS
Type of Device
MANUAL RESUSCITATION BAG
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park 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 Key6605919
MDR Text Key76501308
Report Number3011137372-2017-00189
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5346
Device Lot Number160803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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