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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 11/23/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator generated an alarm, hospital staff did not hear the alarm, and the patient experienced an outcome of death.The customer reported that the unit was in use on a patient at the time of the reported device behavior and patient outcome.This reporter stated that a male patient of unknown age, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.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 ventilation 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 therapy via the v60 device, the device generated an alarm, hospital staff did not hear the alarm, and the patient experienced an outcome of death.The alarm generated by the device was not reported.No relevant laboratory data was reported.No medical intervention was reported.

Manufacturer Narrative

G4:22dec2020.B4:23dec2020.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.Review of the two provided pictures of the diagnostic report (drpt), showed that on (b)(6) 2020 at 11:18:.01 pm, the device¿s alarm loudness was changed from 10 to 1.On (b)(6) 2020 at 02:59.37 am, the alarm loudness was changed from 1 back to 10.Several patient disconnect (1200) alarms were generated on (b)(6) 2020, and the device was powered off on (b)(6) 2020 at 03:05.02 am.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Patient admitted with a diagnosis of coronavirus (covid-19).Relative medical history included orders for do not resuscitate; prescription date not reported.Hospital staff found the patient in asystole, the patient circuit was disconnected from the mask, the device was alarming, hospital staff administered medications; drug names, dosing, routes, and frequencies not reported, but attempts to resuscitate were unsuccessful.The specific details of the do not resuscitate order were not provided.There is no information to support that a malfunction occurred.The device behaved as intended when the users decreased the alarm loudness from the highest setting of 10 to the lowest setting of 1.This resulted in the audio alarm loudness decreasing from 76 decibels to 62 decibels (respironics v60/v60 plus ventilator, user manual, publication number 1047358, revision u, september 2019, page 11-8).The trending analysis indicates that there is no systemic issue.Therefore no further investigation or action is warranted at this time.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: 10987702
• MDR Text Key: 220889655
• Report Number: 2031642-2020-04470
• 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: 11/23/2020

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?: No
• 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: 11/23/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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