MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM; RESUSCITATION DEVICES

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.

• Brand Name: SUPERNO2VA SATELLITE KIT MEDIUM
• Type of Device: RESUSCITATION 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 Key: 11024385
• MDR Text Key: 230682871
• Report Number: 8030673-2020-00135
• Device Sequence Number: 1
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443(17)220731(10)0004130365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020281
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPERNO2VA SATELLITE KIT MEDIUM
• Device Catalogue Number: SSM-20
• Device Lot Number: 0004130365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• 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
• Patient Sequence Number: 1