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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON 22MM SGL HTD LIMB CIRC KIT; HUMIDIFIER NEBULIZER KIT
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HUDSON 22MM SGL HTD LIMB CIRC KIT; HUMIDIFIER NEBULIZER KIT Back to Search Results
Model Number IPN913836
Medical Device Problem Code Melted (1385)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/04/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.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 or Problem Description
Complaint from maude database: heated high flow cannula system (teleflex neptune heater an conchasmart breathing system with single limb) was found off the patient laying on the patient's bed.The heater was on and the flowmeter was on.An area of the corrugated tubing was observed to be melted with an open hole.The patient was on bipap.No injury to the patient.Treatment start on (b)(6) 2021.Diagnosis for covid-19, severe ards.
 
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Brand Name
HUDSON 22MM SGL HTD LIMB CIRC KIT
Common Device Name
HUMIDIFIER NEBULIZER KIT
MDR Report Key11968654
Report Number3004365956-2021-00192
Device Sequence Number19626396
Product Code OGG
UDI-Device Identifier14026704660398
UDI-Public14026704660398
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberIPN913836
Device Catalogue Number870-19KIT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/19/2021
Initial Report FDA Received Date06/09/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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