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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL; STRAIGHT CONN 22ODX22ID,W/PORT
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VYAIRE MEDICAL VYAIRE MEDICAL; STRAIGHT CONN 22ODX22ID,W/PORT Back to Search Results
Model Number 004081
Device Problems Connection Problem (2900); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
The plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator. report indicates this is adverse event, but does not indicate adverse effect on the patient.
 
Manufacturer Narrative
Reportable as this could cause an air link and delay patient ventilation.
 
Manufacturer Narrative
Reportable as this could cause an air link and delay patient ventilation.The complaint of "the plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator." regarding part 004081 was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
 
Event Description
The plastic cap that is attached does not stay closed and pops open with any breath delivered by the ventilator. report indicates this is adverse event, but does not indicate adverse effect on the patient.
 
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Brand Name
VYAIRE MEDICAL
Type of Device
STRAIGHT CONN 22ODX22ID,W/PORT
Manufacturer (Section D)
VYAIRE MEDICAL
productos urologos de mexico s
no. 85 parque indust.mexicali
mexicali baja california, mexico 21397
MX  21397
Manufacturer (Section G)
VYAIRE MEDICAL
productos urologos de mexico s
no. 85 parque indust.mexicali
mexicali baja california, mexico 21397
MX   21397
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key18965559
MDR Text Key338603284
Report Number8030673-2024-01003
Device Sequence Number1
Product Code BZA
UDI-Device Identifier10190752152595
UDI-Public10190752152595
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number004081
Device Catalogue Number004081
Device Lot Number0004254980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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