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

Model Number MS BODY / DIFF RT SES DLCO FRCPL RAW

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

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 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
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hochberg, 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hochberg, 97204 ; GM 97204
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 9747180
• MDR Text Key: 198544093
• Report Number: 9615102-2020-00113
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892905181
• UDI-Public: (01)04250892905181
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/24/2020
• 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