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

Model Number V60

Device Problems No Display/Image (1183); Unexpected Shutdown (4019)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 12nov2020.

Event Description

A customer reported to philips that while in use on a patient, the respironics v60 ventilator¿s screen displayed white lettering, went blank, then the device shut down, and the patient underwent an intubation procedure.The customer reported that the unit was in use on a patient at the time of the reported device symptom and reported adverse event.

Manufacturer Narrative

G4:11dec2020.B4:14dec2020.The device was evaluated by the hospital's biomedical technician with assistance from a philips remote service engineer (rse) and it was determined that the ribbon cable connecting the data acquisition pcba to the motor controller pcba was not seated correctly.The biomedical technician reseated the ribbon cable connecting the data acquisition pcba to the motor controller pcba.The device passed all performance verification testing and was placed back into use.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the 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 ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, hospital staff placed the patient on the v60 device without connecting the device to the wall mounted oxygen source in the room or to any oxygen tanks, the device generated a low oxygen supply pressure alarm, the device¿s screen displayed white lettering, went blank, then the device shut down, and the patient underwent an intubation procedure.It is unknown if the patient was placed on another ventilator.No relevant laboratory data was reported.As of (b)(6) 2020, the outcome of the patient being intubated is unknown.The reported device symptom of the screen being in an inoperable condition, was caused by the ribbon cable that was not seated correctly.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: 10831584
• MDR Text Key: 216088339
• Report Number: 2031642-2020-04153
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 10/30/2020

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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.
• Patient Outcome(s): Life Threatening