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

Model Number JAEGER

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

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2019

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.A vyaire technical support initiated a warranty exchange in which the burnt-smelling module was received.The burnt module was received and was warranted for an exchange for a replacement module to be sent to the customer to resolve the issue.

Event Description

The customer reported while using the calculator, pulmonary function data master screen device; the customer noted a burnt smell when the flap control unit was not functioning.The customer reported there was no patient involvement associated with the event.

• Brand Name: JAEGER
• 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; leibnizstrasse 7; hochberg, 97204 ; GM 97204
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8547170
• MDR Text Key: 143038184
• Report Number: 9615102-2019-00103
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 10846446021714
• UDI-Public: (01)10846446021714
• 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: 03/11/2019

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: JAEGER
• Device Catalogue Number: 001-175452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2011
• 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