MAUDE Adverse Event Report: SENSORMEDICS CORPORATION / VYAIRE MEDICAL, INC. PULMONARY FUNCTION TEST; SPIROMETER, DIAGNOSTIC

Model Number M0117738351010E

Device Problem Difficult to Open or Close (2921)

Patient Problem Emotional Changes (1831)

Event Date 02/11/2021

Event Type  Injury  

Event Description

Door latched with patient inside for test, door latch malfunction and could not open door for patient to exit.Patient was very emotionally distressed due to the event.Fda safety report id # (b)(4).

• Brand Name: PULMONARY FUNCTION TEST
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): SENSORMEDICS CORPORATION / VYAIRE MEDICAL, INC.
• MDR Report Key: 11602138
• MDR Text Key: 243769648
• Report Number: MW5100465
• Device Sequence Number: 1
• Product Code: BZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0117738351010E
• Device Catalogue Number: 773835-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 55 YR