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

Model Number V60

Device Problem Decrease in Pressure (1490)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 19mar2020.

Event Description

The customer reported that the ventilator alarmed due to oxygen pressure being low.The device was being used for treatment when the reported event occurred; however, there was no patient harm.The manufacturer's international service technician evaluated the device and confirmed the reported problem.The service technician replaced the data acquisition board and the reported problem was resolved.

Manufacturer Narrative

G4: 01apr2020.B4: 06apr2020.H11: b5 correction to problem statement: the customer reported that the ventilator produced the proximal pressure sensor autozero diagnostic failure.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: 9857852
• MDR Text Key: 186683840
• Report Number: 2031642-2020-00973
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)00884838025776
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER