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); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problems Cardiopulmonary Arrest (1765); Distress (2329)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Event date: (b)(6) 2020.Report date: 16dec2020.

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator¿s screen went black, the device shutdown and stopped ventilating the patient, and the patient experienced cardiopulmonary arrest.The customer reported that the unit was in use on a patient at the time of the reported device symptom and adverse event.This reporter stated that a (b)(6) years old female patient of unknown height and weight was admitted to a hospital 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 bi-level positive airway pressure (bipap) therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving bipap therapy via the v60 device, when a respiratory therapist entered the patient¿s room, the screen on the v60 ventilator was black with a small message in white lettering stating "flow maintenance", the device was powered off and not ventilating the patient, the device did not generate any alarms, the patient was in distress, their condition deteriorated into cardiopulmonary arrest, cardiopulmonary resuscitation efforts were administered, the patient underwent an intubation procedure; details not reported, was placed on another ventilator and was prescribed invasive therapy; ventilator brand, model, and prescription not reported, and was admitted to the hospital's intensive care unit (icu).No relevant laboratory data was reported.As of (b)(6) 2020, the patient remains admitted to the icu, intubated, receiving mechanical ventilation therapy.

Manufacturer Narrative

G4:22jan2021, b4:25jan2021.There was no request for a field service engineer (fse) onsite visit in regards to this allegation.There was no request for technical support regarding this allegation.Philips is unable to confirm the customer¿s allegation since there was no technical support requested.No diagnostic reports were provided for review.No error codes were reported.The customer sequestered the device and stated that they would contact philips if they needed assistance.Device resolution data is not available.The device remains at the customer site and no further evaluation is required at this time.Philips has already contacted the customer many times but the customer still refuse to provide any details about the injury event and did not request philips field service engineer test the unit.No conclusion can be drawn as the customer declined to provide additional information and declined to have the equipment evaluated.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:(b)(6) 2021.B4:(b)(6) 2021.While admitted on an unknown date, the patient was prescribed bi-level positive airway pressure (bipap) therapy and high flow therapy as needed with meals via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving high flow therapy via the v60 device, when a respiratory therapist entered the patient¿s room, the screen on the v60 ventilator was black with a small message in white lettering stating "flow maintenance".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: 11020902
• MDR Text Key: 221828789
• Report Number: 2031642-2020-04578
• 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,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• 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): Life Threatening
• Patient Age: 69 YR