MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT LARGE; RESUSCITATION KITS

Model Number	SUPERNO2VA SATELLITE KIT LARGE
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the superno2va satellite kit large 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.

• Brand Name: SUPERNO2VA SATELLITE KIT LARGE
• Common Device Name: RESUSCITATION KITS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11024386
• Report Number: 2050001-2020-00029
• Device Sequence Number: 2850138
• Product Code: OEV
• UDI-Device Identifier: 10190752145467
• UDI-Public: (01)10190752145467(10)0004137838
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: SUPERNO2VA SATELLITE KIT LARGE
• Device Catalogue Number: SSL-20
• Device Lot Number: 0004137838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1