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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT LARGE; RESUSCITATION KITS
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VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT LARGE; RESUSCITATION KITS Back to Search Results
Model Number SUPERNO2VA SATELLITE KIT LARGE
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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported that the superno2va satellite kit large green bag has several holes.The customer confirmed that there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Result of investigation: six 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 LARGE
Type of Device
RESUSCITATION KITS
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11024384
MDR Text Key222030885
Report Number2050001-2020-00028
Device Sequence Number1
Product Code OEV
UDI-Device Identifier10190752111363
UDI-Public(01)10190752111363(10)0004102002(17)220131
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
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPERNO2VA SATELLITE KIT LARGE
Device Catalogue NumberSSL-20
Device Lot Number220131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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