MAUDE Adverse Event Report: PHILIPS HEALTHCARE NORTH AMERICA V60 BIPAP

Model Number V60

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Event Description

This is a (b)(6) male admitted from the emergency department with acute respiratory failure on (b)(6) 2015.The patient was placed on bipap v60 at 17:30.Within approximately 10 minutes, the screen went black and said vent inoperative with a message cold of "100a data acquisition pcba adc failed." patient was taken off bipap and placed on a non-rebreather.Bipap was producing no ventilation.Patient did not have any adverse outcome.

• Brand Name: V60 BIPAP
• Type of Device: V60 BIPAP
• Manufacturer (Section D): PHILIPS HEALTHCARE NORTH AMERICA; 3000 minuteman rd.; andover MA 1810
• MDR Report Key: 5409611
• MDR Text Key: 37538188
• Report Number: MW5059987
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 138