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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Model Number IPN049284
Device Problem Failure to Deliver (2338)
Patient Problem Respiratory Arrest (4461)
Event Date 01/07/2021
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Complaint was reported "patient has a trach with high humidity trach mask.Patient had a respiratory arrest secondary to mucus plug.This high humidity set-up does not provide the same amount of humidity as the previous set up.Cannot determine that the product caused the mucus plug and respiratory arrest, however, more humidification would have reduced the risk of developing a mucus plug".Patient had a respiratory arrest secondary to mucus plug.The teleflex humidity set-up was changed to the thera-mist lvn-high flow (smiths medical)set-up.Additional information was requested but not received at the time of this report.Patient condition unknown.
 
Event Description
Complaint was reported "patient has a trach with high humidity trach mask.Patient had a respiratory arrest secondary to mucus plug.This high humidity set-up does not provide the same amount of humidity as the previous set up.Cannot determine that the product caused the mucus plug and respiratory arrest, however, more humidification would have reduced the risk of developing a mucus plug".Patient had a respiratory arrest secondary to mucus plug.The teleflex humidity set-up was changed to the thera-mist lvn-high flow (smiths medical)set-up.Additional information was requested but not received at the time of this report.Patient condition unknown.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028, SHELFPAK
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11323753
MDR Text Key231700121
Report Number3004365956-2021-00039
Device Sequence Number1
Product Code CAF
UDI-Device Identifier14026704627735
UDI-Public14026704627735
Combination Product (y/n)N
PMA/PMN Number
K141214
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 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN049284
Device Catalogue Number031-28
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED; NONE REPORTED
Patient Outcome(s) Life Threatening; Required Intervention;
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