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

Model Number V60

Device Problems Break (1069); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06apr2020.

Event Description

It was reported that the unit had flow issues, a pressure accuracy failure during maintenance, a broken cooling fan and shut down.There was no patient involvement.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The unit was failing pressure accuracy testing at 1cmh2o.The fse opened the cover and checked the ribbon cable connections to the motor controller and data acquisition board.When the data acquisition board was repositioned on the gas delivery system, the unit was powered up and went into a hard failure and shut down.The fse replaced the cooling fan, gas delivery system (gds), data acquisition to motor controller board cable and fan guard to address the findings.After parts were replaced, the unit passed testing and the issues were resolved.

Manufacturer Narrative

G4: 31jul2020.B4: 05aug2020.The data acquisition cable was returned to manufacturer to failure investigation (fi) for analysis.No fault found.Unable to replicate reported failure.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is not a relationship of the device to the reported problem.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: 9929215
• MDR Text Key: 188689784
• Report Number: 2031642-2020-01185
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1