MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION VMAX PFT MACHINE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

The respiratory therapist was conducting a pulmonary function test (pft) on a patient when the arm of the pft machine fell off.Therapist grabbed the arm to prevent it from hitting the patient.The machine is less than a year old and this was an unexpected event.The manufacturer was notified.

• Brand Name: VMAX PFT MACHINE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION 207, INC. DBA CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5115625
• MDR Text Key: 27213050
• Report Number: 5115625
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/30/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO