MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM); RESUSCITATION DEVICES

Model Number SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)

Device Problem Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review did not show any deviations to manufacturer specifications.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the abs bag arm connector elbow of supernova nasal pap ventilation system was put on backwards not allowing it to connect to the anesthesia machine.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: SUPERNOVA NASAL PAP VENTILATION SYSTEM (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: 11807424
• MDR Text Key: 250025693
• Report Number: 8030673-2021-00169
• Device Sequence Number: 1
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443(10)0004178443
• 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: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM)
• Device Catalogue Number: SSM-20
• Device Lot Number: 0004178443
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1