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

Model Number V60

Device Problems No Flow (2991); Pressure Problem (3012)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09may2020.

Event Description

It was reported that the unit had no flow or pressure.It is unknown if the device was in use at the time of the event; however, there was no patient harm reported.The manufacturer's remote service technician performed troubleshooting with the customer.The customer reported that there were no error code logs and the pneumatic screen reads the average flow is 8 liters per minute (lpm).The customer cycled the unit to normal ventilation and the pneumatic screen read the average flow as 240 lpm.The technician recommended that the customer replace the flow sensor assembly.The customer reported that the flow sensor assembly was replaced and the issue persisted.The technician then advised the customer to replace the blower and/or motor controller board.The customer reported that the blower had an unknown fluid inside.The customer reported that the blower was replaced to resolve the issue.

Manufacturer Narrative

G4: 21jul2020 b4: (b)(6) 2020 h11: b1 and h1 updated this reporter stated that a patient of unknown age, gender, height, and weight was admitted to the hospital on an unknown date with a primary diagnosis of coronavirus (covid-19).No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on a date not reported, the patient was prescribed non-invasive (niv) positive pressure ventilation (ppv) via the respironics v60 ventilator in spontaneous/timed (s/t) mode; settings not reported, with heated humidification pro re nata (prn), and intermittent high flow therapy (hft) via comforflow or airvo; lot numbers and expiration dates not reported, with orders to titrate in order to maintain a peripheral capillary oxygen saturation (spo2) of >90% and comfort.While admitted and on a date not reported, the patient was alert and oriented times three, receiving ventilation therapy via the v60 ventilator, the patient experienced an event of severe hypoxemia with an spo2 in the low 60% range, the ventilator was in an inoperative state with a black screen displayed, the respiratory therapist immediately transitioned the patient to hft with approximate settings of 60 liters per minute at 100% fraction of inspired oxygen (fio2), and the event of severe hypoxemia immediately resolved.The respiratory therapist reported the v60 device was able to be powered on immediately from "off" state, alarms were present on the screen, but was unable to recall the verbiage of text presented on the display.There was no excessive condensation or rainout noted.Upon verification of the setup, customer was unable to confirm, however states "more than likely" the device was not being used with v60 stand circuit support arm and this may have contributed to water ingress probability.The customer states disinfection with bleach and oxycide is standard of practice within their facility and excessive moisture may have possibly been introduced during the cleaning procedures.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: 10041528
• MDR Text Key: 190766392
• Report Number: 2031642-2020-01694
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2020
• 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
• Date Manufacturer 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
• Patient Outcome(s): Life Threatening