MAUDE Adverse Event Report: VYAIRE MEDICAL MASTERSCREEN BODY/DIFFUSION; CALCULATOR, PULMONARY FUNCTION DATA

Model Number MASTERSCREEN BODY/DIFFUSION

Device Problem Electrical Shorting (2926)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).Vyire medical performed an investigation and found out that the root cause was attributed to life block - (capacitor) short-cut on life board.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 masterscreen experienced a shutter driver burning.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: MASTERSCREEN BODY/DIFFUSION
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11399189
• MDR Text Key: 234286610
• Report Number: 9615102-2021-00118
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 10846446021714
• UDI-Public: (01)10846446021714
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2021

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
• Device Operator: Health Professional
• Device Model Number: MASTERSCREEN BODY/DIFFUSION
• Device Catalogue Number: 001-175452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1