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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RESUSCITATOR BAG ADULT W/; RESUSCITATOR BAG, MANUAL
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TELEFLEX MEDICAL HUDSON RESUSCITATOR BAG ADULT W/; RESUSCITATOR BAG, MANUAL Back to Search Results
Catalog Number 157100300
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional clarification of the event requested and received states: "at the end of the bag where the 02 reservoir is there is a plastic disk with the valves in it.It attaches to the bag portion that you squeeze.Where these two join it is not sealing and air leaks and you are not able to build any pressure." the device involved in this complaint has not been returned by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "not making a seal and when ventilating the air flows back into the reservoir bag." alleged issue reported as occurred during use.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.
 
Event Description
Customer complaint alleges "not making a seal and when ventilating the air flows back into the reservoir bag." alleged issue reported as occurred during use.There was no report of patient injury or consequence.
 
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Brand Name
HUDSON RESUSCITATOR BAG ADULT W/
Type of Device
RESUSCITATOR BAG, MANUAL
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 Key7416915
MDR Text Key105261117
Report Number3011137372-2018-00099
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number157100300
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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