MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH MASTERSCREEN; CALCULATOR, PULMONARY FUNCTION DATA

Model Number MASTERSCREEN BODY

Device Problems Fumes or Vapors (2529); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire medical has not received the suspect device/component for evaluation.

Event Description

The customer reported to vyaire medical a burnt or charred smell coming from the system box of the masterscreen body/diff.The customer was unable to measure gas calibration.The customer reported there is no patient involvement associated with the event.

• Brand Name: MASTERSCREEN
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg,
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9476380
• MDR Text Key: 202417086
• Report Number: 9615102-2019-00112
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892905204
• UDI-Public: (01)04250892905204
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2019

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
• Device Catalogue Number: V-175452
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: No
• 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