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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING
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TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Catalog Number 1058
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2020
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
Customer reported "the bag does not inflate, this being extremely important because the patient's life is at risk." no patient harm was reported.The patient's condition was reported as fine.
 
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Brand Name
HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT
Type of Device
MASK, OXYGEN, NON-REBREATHING
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10462946
MDR Text Key204692658
Report Number3004365956-2020-00159
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,distri
Type of Report Initial
Report Date 08/13/2020
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 Number1058
Device Lot Number74C1800587
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/13/2020
Initial Date FDA Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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