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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 5372
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported air was not going through the bag and the bag was hard. The device was being used on an or patient under distress. It was reported that a new bag was obtained and the o2 sats came back up. Patient condition was reported as fine.
 
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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 Key9234615
MDR Text Key190842872
Report Number3011137372-2019-00361
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 10/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5372
Device Lot Number160919
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
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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