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

Model Number	MASTERSCREEN BODY
Medical Device Problem Codes	Device Emits Odor (1425); Fumes or Vapors (2529)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the following: defective masterscreen control unit with a burning smell.The customer reported supposedly there was a fire and the control unit was dropped, became hot and melted.There was no patient involvement associated with the event.

• Brand Name: MASTERSCREEN
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; SZ 97204
• MDR Report Key: 9504170
• Report Number: 9615102-2019-00113
• Device Sequence Number: 1878521
• Product Code: BZC
• UDI-Device Identifier: 04250892905204
• UDI-Public: (01)04250892905204
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: MASTERSCREEN BODY
• Device Catalogue Number: V-175423
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1