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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
Model Number IPN914089
Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)
Patient Problem Death (1802)
Event Date 10/08/2020
Event Type  Death  
Manufacturer Narrative
(b)(4). A physician at the user facility reported the death of the patient is not linked with the issues faced with the device. It was reported the patient was in cardiac arrest prior to use of the device.
 
Event Description
The complaint is reported as: "during a resuscitation intervention following a vascular cardiac arrest on (b)(6) 2020, the connection/tubing between device and the mobile oxygen cylinder could not be done correctly and the movements of the tubing caused disconnections. The consequences: delay increased for the intervention and disrupted resuscitation. The female patient died. " it was reported "the device was not involved in the death, as the patient could not have been resuscitated anyway. ". It was also reported "this issue delayed the start of resuscitation and needed staff to provide the oxygen supply. ".
 
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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 Key10803472
MDR Text Key215116058
Report Number3011137372-2020-00241
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN914089
Device Catalogue Number45372
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
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

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
Treatment
NONE REPORTED.
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