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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 Problems Collapse (1099); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges "when using the insufflator, the valve remained "collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
 
Manufacturer Narrative
Qn#(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was not returned; however, the customer provided a photo for evaluation.The photo was reviewed and this issue would be detected at the connector assembly and inspection process at the manufacturing facility.
 
Event Description
Customer complaint alleges "when using the insufflator, the valve remained "collapsed" so another device was used." it was reported there was a delay in ventilation, but the delay caused no clinical consequences for the patient.Another device was available for use.
 
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Brand Name
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Type of Device
VENTILATOR,EMERGENCY,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 Key6308392
MDR Text Key66722640
Report Number3011137372-2017-00031
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number45372
Device Lot Number160809
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2017
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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