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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

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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 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
"the value in the ambu did not open and air did not flow to the patient. Required a 2nd intubation. " no patient harm was reported. Patient's condition reported to be "fine". Additional information was requested, but not available at the time of this report.
 
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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 Key9636741
MDR Text Key189863845
Report Number3011137372-2020-00019
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 01/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
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 Unkown

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