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

Model Number JAEGER

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not available for evaluation.Due to the device not being available for analysis, no further evaluation can be completed at this time.

Event Description

The customer reported to vyaire medical that the lung testing system device was leaking.The equipment was not working properly and the facility maintenance staff was notified about the issue which had immediately replaced the defective accessories.Due to this device malfunction, the patient's treatment time was delayed.The device was in use on a patient at the time of the incident; however, there was no patient harm associated with the reported issue.

• Brand Name: MASTERSCREEN PFT BODY
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8925567
• MDR Text Key: 155350988
• Report Number: 9615102-2019-00108
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892900810
• UDI-Public: (01)04250892900810(11)170808
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JAEGER
• Device Catalogue Number: 172520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/23/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR