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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 11/14/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not available for return, as it was discarded due to possible covid-19 contamination. Also photos was not provided by the customer. No further evaluation can be completed at this time. 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 medium experienced multiple tears in bags where they have been creased in packages. The reported issue was detected during patient use. The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand NameSUPERNO2VA SATELLITE KIT MEDIUM
Type of DeviceRESUSCITATION DEVICES
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada v?a de la producci?n
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
peter sparacio
26125 n. riverwoods blvd.
mettawa, IL 60045
8333273284
MDR Report Key11024385
MDR Text Key230682871
Report Number8030673-2020-00135
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were 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
Device Model NumberSUPERNO2VA SATELLITE KIT MEDIUM
Device Catalogue NumberSSM-20
Device Lot Number0004130365
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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