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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON MASK, NON-RESEARCH W/SAFETY VENT, ELONGA; OXYGEN MASK - NONREBREATHING
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TELEFLEX HUDSON MASK, NON-RESEARCH W/SAFETY VENT, ELONGA; OXYGEN MASK - NONREBREATHING Back to Search Results
Catalog Number 1059
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
The event reported as: the customer alleges tht the reservoir bag did not inflate with 10l/min air flow.
 
Manufacturer Narrative
The device sample was received by the mfr, but the investigation is incomplete at the time of this report.The dhr (device history record) was reviewed and showed that there were no issues related to a functional test of the product or its components during the procedure of the material.Current production was verified to identify any issue that can lead to the reported defect and no issues were found.
 
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Brand Name
HUDSON MASK, NON-RESEARCH W/SAFETY VENT, ELONGA
Type of Device
OXYGEN MASK - NONREBREATHING
Manufacturer (Section D)
TELEFLEX
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3966568
MDR Text Key19922348
Report Number3004365956-2014-00237
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1059
Device Lot Number02G1200538
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/18/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2012
Is the Device Single Use? Yes
Patient Sequence Number1
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