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

Model Number V60

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03aug2020.

Event Description

The customer reported misalignment in the touchscreen.No patient involvement or harm reported at the time the issue was discovered.The service technician confirmed the reported issue and the misalignment in the touchscreen was large and it was unable to be operated at the post-use check.It was pointed out that they had addressed the issue several times by calibration but the frequency was too high.

Manufacturer Narrative

G4:29dec2020.B4:30dec2020.A central processing unit (cpu) was returned for analysis.Visual inspection of the cpu board revealed no evidence of damage or contamination.An investigation was performed and the cpu board was tested and no failures were identified.The ventilator restarted due to anomalies detected during operation error could not be duplicated.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: 02nov2020 b4: 05nov2020 a touchscreen assembly was returned for analysis.Visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.An investigation was performed and the ul_lr / ur_ll resistance and resistance ratio were out of specification.Fault are found on this returned touchscreen.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: 08oct2020.B4: 09oct2020.D4: udi#: (b)(4).The reported issue was confirmed.Service technician attempted to calibrate touchscreen but failed since the misalignment in the touch position was large.During the repair of the unit, error code consistent with ventilator restarted due to anomalies detected during operation was confirmed in the error record.While the error was not duplicated by operational check, central processing unit (cpu) was recommended to be replaced.Since misalignment in the touch position was confirmed, touchscreen was replaced to resolve the reported issue.The cpu board was replaced to prevent recurrence.Unit was checked overall, cleaned, run in tests and functionally tested.Confirmed the software version is 2.30.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: 10359949
• MDR Text Key: 202554394
• Report Number: 2031642-2020-02620
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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