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

Model Number V60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 27feb2020.

Event Description

The customer reported an undisclosed patient incident that occurred while the v60 vent was in clinical use on a patient.

Manufacturer Narrative

G4: 02feb2020 b4: (b)(6) 2020 h11:b1:h1: updated: the device was in use on a patient when the reported problem occurred.Undisclosed patient incident.G4: 15jul2020 b4: (b)(6) 2020 the device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer is reported that the unit failed the pressure accuracy testing.The customer installed a new data acquisition board, a new v60 battery, completed the v60 performance verification, and the device has been returned to service.No relevant medical history, relevant past drug history, relevant concomitant medical products, or relevant laboratory data was reported.Limited information was provided for this safety report.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.

• 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: 9764637
• MDR Text Key: 190056805
• Report Number: 2031642-2020-00656
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER