RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problems
Alarm Not Visible (1022); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
|
Patient Problem
Low Oxygen Saturation (2477)
|
Event Type
Injury
|
Manufacturer Narrative
|
Event date: (b)(6) 2020.Date of this report: 09oct2020.
|
|
Event Description
|
It was reported to philips that the device failed to alert patient trigger to the clinicians.The mask was removed, but device still says patient trigger at 80%.The device was in use at the time of the event.The patient was connected to the device, and the ventilator stated leak of 50l and tidal volume dropped to 150ml.The staff attempted to swap out the mask, but the patient was required to be bagged as they were not breathing.On removal of mask/patient, the machine continued to say patient triggering at 80%.The customer requested that the device be returned to the philips bench for evaluation and repair.
|
|
Manufacturer Narrative
|
G4: 01dec2020.B4: 08dec2020.A philips repair bench technician evaluated the device.The technician was not able to reproduce the reported device issue.There were no parts were replaced in regards due to the device allegation and the device passed all performance verification testing.While at the repair bench, the device was found to be on the affected listed (ual) fco86600050.Therefore, the power management pcba was replaced and the device was then retuned to the customer.The pm board was replaced per fco86600050, this is unrelated to the original complaint from the customer.The device's software version at the time of the reported event was 2.10.The device settings during the report event were spontaneous / timed (s/t) mode, inspiratory positive airway pressure (ipap) 40 centimeters of water (cmh2o), expiratory positive airway pressure (epap) 21 cmh2o, and a respiratory rate of 10 breaths per minute.The event of apnea resolved, the medical interventions of manual ventilation and cardiopulmonary resuscitation ceased, and the patient was administered a new mask; brand and model not reported, and ventilation treatment continued using the v60 ventilator.The date of the event was not reported.However, review of the provided diagnostic report (drpta), showed that the probable last date of use of the device on a patient was on (b)(6) 2020 continuously to (b)(6) 2020, and the device generated several patient disconnect (1200) alarms, and no error codes were generated.There is no information to support that a malfunction occurred.Philips was unable to determine the cause of the reported symptom as it could not be reproduced.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: 04nov2020.B4: 04nov2020.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital¿s intensive care unit on an unknown date with a poor prognosis and the admitting diagnosis not reported.Relevant medical history included multiple co-morbidities; diagnoses and diagnostic dates not reported, and non-compliance with medical intervention.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on an unknown date, the patient was receiving non-invasive therapy via the v60 device via a mask; brand and model not reported, the patient was triggering 90%, then the tidal volume dropped to 150 milliliters (ml), the device displayed a leak of 50l/min, hospital staff then checked the patient, removed the mask, patient was found to be apneic, cardiopulmonary resuscitation efforts were administered, and resuscitation efforts were ceased upon decision from treating medical team.While the mask was removed from the patient, the v60 did not generate a patient disconnect alarm, but continued to display the patient was triggering at 80%.No relevant laboratory data was reported.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.
|
|
Search Alerts/Recalls
|
|
|