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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM; RESUSCITATION DEVICES
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VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM; RESUSCITATION DEVICES Back to Search Results
Model Number SUPERNO2VA SATELLITE KIT MEDIUM
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
No sample or picture was provided for the investigation.Therefore, defect reported was not confirmed.
 
Event Description
The customer reported that the superno2va satellite kit medium green bag has several holes.The customer confirmed that there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Result of investigation: four samples received for investigation.A visual inspection was performed and found that the component is damaged.The root cause is determined to be manufacturing process - supplier manufacturing process scar 2020000048 was initiated to obtain a further investigation by our supplier.
 
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Brand Name
SUPERNO2VA SATELLITE KIT MEDIUM
Type of Device
RESUSCITATION DEVICES
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11024391
MDR Text Key251612575
Report Number8030673-2020-00134
Device Sequence Number1
Product Code OEV
UDI-Device Identifier10190752111356
UDI-Public(01)10190752111356(10)000410997(17)220308
Combination Product (y/n)N
PMA/PMN Number
K020281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/17/2020
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
Device Operator Health Professional
Device Model NumberSUPERNO2VA SATELLITE KIT MEDIUM
Device Catalogue NumberSSM-20
Device Lot Number220308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received01/29/2021
Supplement Dates FDA Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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