RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2020.Date of report: 14jul2020.
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Event Description
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The hospital biomedical engineers (bme) upgraded their v60s from software version 2.1 to 3.0 and enabled the high flow therapy (hft).The biomedical engineer (bme) reported that the device failed the verification check as it did not provide a high priority disconnect alarm when in ventilation / self test mode.After a period of time the proximal pressure alarm announced.The customer uses the fisher and paykel mr950 and 950a61 circuit.The bme used the circuit and humidifier set up used by the hospital icu department.The hospital's bme verified the reported problem.The same testing was performed using the philips 1065832 circuit and the device passed the verification check.The customer reported that the unit was not in use on a patient.
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Manufacturer Narrative
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G4: 15sep2020.Information was received that the customer biomedical engineer reverted the ventilators software from 3.0 to 2.10.Troubleshooting with the customer was performed and it was found that the customer was using a mr950 humidifier/water chamber/patient circuit combination.The customer was advised that the mr950 is not an approved accessory to be used with the ventilator.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.
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Manufacturer Narrative
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15sep2020 (b)(6) 2020.Further investigation indicated that the customer was using an unapproved humidifier and circuit.Troubleshooting with the customer was performed, and it was found that the customer was using mr950 humidifier/water chamber/patient circuit combination.These types of accessories are not recommended parts to be used on the v60 ventilator, as indicated in the operator's manual.The customer was advised that the mr950 is not an approved accessory to be used with the v60 ventilator.A review of the complaint indicated that the event was found during performance verification testing (pvt).There was no patient involvement, and the protection against fault functioned correctly at the time of the event occurred.The pvt is pre-patient testing before the ventilator can be used on a patient.Therefore, any malfunction found during pvt will always be found and addressed before the ventilator can be put into service.Based on the information, the issue does not meet the reportability criteria.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.
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