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

Model Number V60

Device Problems Device Alarm System (1012); No Display/Image (1183)

Patient Problem Death (1802)

Event Date 12/22/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05jan2021.

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator displayed a black screen, did not generate an alarm, and the patient experienced an outcome of death.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.The customer reported that the unit was in use on a patient at the time of the reported device behavior and patient outcome.

Manufacturer Narrative

G4:(b)(6) 2021 b4:(b)(6) 2021 this reporter stated that a 66 years old male patient weighing 82 kilogram with a height of 69 inches was admitted to a hospital¿s critical care unit on (b)(6) 2020 with admitting diagnoses of coronavirus (covid-19), atelectasis, and atrial flutter.Relevant medical history included acute bronchitis, chronic obstructive pulmonary disease (copd), chest pain, emphysema, and 20 cigarettes daily for 50 years, high risk respiratory failure due to very poor forced expiratory volume (fev1); dates of diagnoses not reported.Relevant past drug history and relevant concomitant medical products were reported.While admitted on (b)(6) 2020, the patient was prescribed intermittent bi-level positive airway pressure (bipap) ventilation therapy via the respironics v60 ventilator, due to left lung atelectasis, high risk respiratory failure due to very poor forced expiratory volume (fev1), left sided pneumonia, acute copd exacerbation, nicotine dependence, atrial fibrillation, and a guarded prognosis due to end stage copd.The v60¿s software version is 3.0.The prescription included a respironics patient circuit, respironics as 541 full face mask ¿ size medium, vyaire ¿ air life bacterial filter, hudson rci ¿ micromist nebulizer, ipap 22, epap 5, set respiratory rate 14, spontaneous timed mode.The v60¿s settings included alarm limits of high pressure 26, low pressure 6, high respiratory rate 40 ¿ low respiratory rate 10, high tidal volume 1600 ¿ low tidal volume 200, and alarm volume escalation feature enabled.While admitted on (b)(6) 2020, the registered nurse caring for the patient entered the patient¿s room and found the v60 was off, the device displayed a black screen, no alarms were generated, the patient had removed their mask, the mask was on the floor and still connected to the v60, the patient experienced an event of pulseless electrical activity (pea), cardiopulmonary resuscitation efforts including chest compressions were administered, and the patient experienced an outcome of death.Relevant laboratory data included procalcitonin 0.28 micrograms per liter (g/l), white blood cell count 23.51, red blood cell count 3.33, hemoglobin 9.9, hematocrit 39.1, absolute neutrophils 22.33, sodium 138, chloride 98, enzymatic carbon dioxide 42, blood urea nitrogen 27, glucose 133, d dimer 581, and pro brain natriuretic peptide 2164.The cause of death was due to pea ¿ unable to maintain blood pressure or o2 saturation even with effective chest compressions/hypoxemia to asystole.The device's serial number was identified to be listed for the fco 86600050 implementation.No parts were replaced.The device passed all performance verification tests and was placed back into use with the customer.Post performance verification testing, the power management pcba was changed due to fco 50.Philips was not able to confirm the reported malfunction.Since, the problem could not be recreated, the cause 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11121441
• MDR Text Key: 225245361
• Report Number: 2031642-2021-00034
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2011
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 82