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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09mar2020.

Event Description

It was reported that the unit's "breaths per minute" was not correct.The device was in use at the time of the event; however, there was no patient harm.The manufacturer's field service engineer (fse) performed troubleshooting and was unable to confirm the reported issue.The fse did note that the unit declared a low leak co2 rebreathing risk error.When the fse inspected the unit's blower assembly and gas delivery system (gds), there was an unknown yellow liquid inside.The fse replaced the gds and blower assembly and the issue was resolved.

Manufacturer Narrative

G4: 25jul2020.B4: 28jul2020.Gas delivery system (gds) assembly and blower motor (blower motor assembly) were returned for analysis.Visual inspection revealed the revealed no anomalies.Failure investigation (fi) technician installed the gds assembly into a fi ventilator to duplicate the reported issue.During the unit testing the air flow sensor failed, the reported issue was duplicated, and the fi technician identified that a component in reference designation u1 on the air flow sensor out of specification.There was no fault was found with the blower unit.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: 9809152
• MDR Text Key: 190369644
• Report Number: 2031642-2020-00854
• 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: 02/21/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER