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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 Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 12/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "mask on 5372 resuscitation bag was found completely deflated on a code cart during check." no patient involvement was reported.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer complaint alleges "mask on 5372 resuscitation bag was found completely deflated on a code cart during check." no patient involvement was reported.
 
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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
MDR Report Key8236771
MDR Text Key132977115
Report Number3011137372-2019-00029
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/17/2020
Device Catalogue Number5372
Device Lot Number170830
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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