MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 18june2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

Customer contacted technical support (ts) stating that unit had error code messages of 3.3v supply failed, 5v supply failed, and 35v supply failed.Manufacturer's product support engineer (pse) also found fan heating.

Manufacturer Narrative

G4: 08oct2019; b4: 08oct2019.The device was evaluated by the field service engineer and the reported issue was confirmed.The field service engineer replaced the motor controller printed circuit board assembly (pcba) to address the issue.The issue has been resolved, the device has been tested, and the device now functions as intended.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

Customer contacted technical support (ts) stating that unit had error code messages of 3.3v supply failed, 5v supply failed, and 35v supply failed.Manufacturer's product support engineer (pse) also found fan heating.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8708521
• MDR Text Key: 148544780
• Report Number: 2031642-2019-03906
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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: Other
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1