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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO

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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Catalog Number 1607
Device Problem Decoupling (1145)
Patient Problems Death (1802); Respiratory Failure (2484)
Event Date 07/29/2020
Event Type  Death  
Manufacturer Narrative
(b)(4). It was reported the patient's cause of death was possibly respiratory failure, but there is no documentation related to official cause of death. The user facility reported they did not know why the ventilator tubing disconnected, but thought the connection was loose. The user facility also noted the ventilators are loud and the alarms can be difficult to hear. 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. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer reported an incident surrounding a breathing hose coming off a ventilator. The patient was on a portable ventilator for 13 days with high peak pressures. When the provider went into the room, the tubing was disconnected from the ventilator. The patient was on multiple drips and couldn't breathe on his own. Patient was reported to be under a 'do not resuscitate' (dnr) order and therefore no resuscitation attempt was made. The patient died on (b)(6) 2020. The customer reported the inspiratory side hose is loose and prone to come off. Per customer, the high pressure ventilation many patients require can lead to 'pop-offs' of the ventilator tubing from the ventilator equipment.
 
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Brand NameHUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of DeviceCIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX 88275
Manufacturer Contact
victoria sandlin
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key10441859
MDR Text Key203996522
Report Number3004365956-2020-00155
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1607
Device Lot Number74D2000023
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
Treatment
PATIENT ON MULTIPLE DRIPS
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