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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 Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved has been returned to the manufacturer for evaluation, however the evaluation of said device has not been completed at the time of this report.
 
Event Description
Customer complaint reported: "when resuscitation bag was used on patient, health care provider found difficulty with ventilation & exhalation (was able to exhale but it was prolonged).Provider examined the resuscitation set and found that 15 mm connector that attaches to the ett, pushes the duck valve making it difficult to inspire and exhale." no patient harm reported.Patient condition reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer (galemed) for evaluation.Galemed reports the following: a visual exam was performed and it was observed that the duckbill valve was opened.The returned sample was compared with the normal nrv and it was found that the length of the connector outside the cap of the returned sample was shorter than the normal sample.After applying certain force to the connector of the normal nrv, the same defect phenomenon was simulated.Galemed also reports that at the assembly process, 100% expiratory resistance testing is performed on the products and a defect of this type would be detected prior to release.It was determined this complaint defect happened during the transportation or using due to the large outer force impaction.
 
Event Description
Customer complaint reported: "when resuscitation bag was used on patient, health care provider found difficulty with ventilation & exhalation (was able to exhale but it was prolonged).Provider examined the resuscitation set and found that 15 mm connector that attaches to the ett, pushes the duck valve making it difficult to inspire and exhale." no patient harm reported.Patient condition reported as fine.
 
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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 Key8451577
MDR Text Key139825471
Report Number3011137372-2019-00073
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,distri
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/11/2021
Device Catalogue Number5372
Device Lot Number180611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Date Manufacturer Received04/22/2019
Patient Sequence Number1
Treatment
ENDOTRACHEAL TUBE (MANUFACTURER UNKNOWN).; ENDOTRACHEAL TUBE (MANUFACTURER UNKNOWN).; ENDOTRACHEAL TUBE (MANUFACTURER UNKNOWN).
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