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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER VENTILATOR, EMERGENCY, MANUAL

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TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Catalog Number 45372
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported that "the mask can be fully depressed, there is no more air in it. More details about situation : during a cpr, the doctor saw that the mask was air-free and flat. They took another manual resuscitator and this was ok. Afterwards they checked their stock and noticed a total of 4 items with the same problem". No patient harm was reported.
 
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Brand NameHUDSON DISP MANUAL RESUS,ADULT 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 Key10520728
MDR Text Key207751484
Report Number3011137372-2020-00203
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number45372
Device Lot Number190225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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