MAUDE Adverse Event Report: VYAIRE MEDICAL OXYCON PRO; CALCULATOR, PULMONARY FUNCTION DATA

Catalog Number 143900

Device Problem Output above Specifications (1432)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not available to be returned at this time.

Event Description

The customer reported the loud noise and a burning smell coming from the oxycon pro system under the ventilated hood part.The fan component is not moving freely and catching on edges.The customer has requested a warranty replacement for the defective device and the vyaire technical support specialist has processed the order for a new replacement.

• Brand Name: OXYCON PRO
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION GERMANY 234 GMBH; leibenizstrasse 7; hochberg, 97204 ; GM 97204
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8558284
• MDR Text Key: 143372866
• Report Number: 9615102-2019-00104
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• PMA/PMN Number: K992214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 143900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• 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