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

Model Number V60 PLUS

Device Problems Obstruction of Flow (2423); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 27jan2021.

Event Description

A customer reported to philips that while delivering high flow therapy to a patient, the v60 ventilator generated cannot reach target flow alarms, there was an interruption of flow rate to the patient, and the patient experienced an event of decreased peripheral capillary oxygen saturation.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.This complaint was received through the customer feedback process.There was no request for technical support regarding this allegation and there is no record of a service order being opened.Philips is unable to confirm the customers allegation since there was no technical support requested.No diagnostic report was provided for review.The cannot reach target flow is a low priority alarm that may occur during high flow therapy.The alarm is generated when the machine pressure reached its maximum and could not achieve the target flow.The recommended repair is to check the patient, check that the nasal cannula size is appropriate for the flow setting, check that an occlusive interface is not in use, and check the patient circuit for occlusions, kinks, or liquid.The customer reported that the unit was in use on a patient at the time of the reported device behavior and adverse event.No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital's negative pressure room in the step down unit on an unknown date with an admitting diagnosis of coronavirus (covid-19).No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed high flow therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2021, the patient was receiving high flow therapy via the v60 device in the prone position, the device generated cannot reach target flow alarms, there was an interruption of flow rate to the patient, and the patient experienced an event of decreased peripheral capillary oxygen saturation; values not reported, a rapid response was called, the event of decreased oxygen saturation resolved to normal limits, and the patient continued hft on the v60.No relevant laboratory data was reported.The reporter stated that the alarm was generated by an occlusion of the nasal cannula.

• 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: 11240935
• MDR Text Key: 229860380
• Report Number: 2031642-2021-00339
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening