MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC.; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY

Model Number V60

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 04/08/2017

Event Type  malfunction  

Event Description

Patient was being transported on device to icu.During transport the device shut down and stopped delivering pressure to the patient.There was an error code #1006.

• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• MDR Report Key: 6692734
• MDR Text Key: 79262657
• Report Number: 6692734
• Device Sequence Number: 1
• Product Code: MNT
• 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
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 72 YR