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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/23/2019.The manufacturer's remote service technician performed troubleshooting with the customer.The technician recommended that the customer replace the flow sensor assembly.

Event Description

It was reported that the unit was not delivering or reading tidal volumes correctly.When the unit was set to 10 liters per minute (lpm), it was reading 37 lpm.The device was in use at the time of the event; however, there was no patient harm.

Manufacturer Narrative

Mfr received date: (b)(6) 2019.The customer reported replacing the flow sensor assembly and the unit is passing flow testing.The issue was resolved.The device was being used for treatment when the reported event occurred, and there is a relationship between the device and the reported problem.No parts were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.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.

Manufacturer Narrative

G4: 08feb2020, b4: 10feb2020.The gas delivery system (gds) was returned for failure analysis.A visual inspection revealed that the unit was received without the data acquisition board and oxygen valve.Also, one of the support standoffs for the data acquisition board was missing.During testing, it was determined that the unit failed due to the air flow sensor's u1 component drifting out of specification.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: 9226047
• MDR Text Key: 187576911
• Report Number: 2031642-2019-10200
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER.