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

Model Number	MS BODY / DIFF RT SES DLCO FRCPL RAW
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, vyaire has not received the suspect device/component for evaluation.The replacement for handle ms-pft/body was already sent to the customer as a resolution.
Event or Problem Description
The customer reported a burning smell from the cabin.There was no smoke and the body was functioning.There was no patient involvement associated on this event.

• Brand Name: MASTERSCREEN BODY/DIFF
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hochberg, 97204 ; GM 97204
• MDR Report Key: 9747180
• Report Number: 9615102-2020-00113
• Device Sequence Number: 16637688
• Product Code: BZC
• UDI-Device Identifier: 04250892905181
• UDI-Public: (01)04250892905181
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: MS BODY / DIFF RT SES DLCO FRCPL RAW
• Device Catalogue Number: V-175423-13
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1