MAUDE Adverse Event Report: RESPIRONICS INC. V60; BIPAP MACHINE

Model Number V60

Device Problem Computer Software Problem (1112)

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

Event Date 09/30/2016

Event Type  malfunction  

Event Description

Unable to change settings on bipap machine.

• Brand Name: V60
• Type of Device: BIPAP MACHINE
• Manufacturer (Section D): RESPIRONICS INC.; murrysville PA
• MDR Report Key: 6232590
• MDR Text Key: 64284722
• Report Number: MW5067109
• Device Sequence Number: 1
• Product Code: MNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2016

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: V60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 69