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

Model Number V60

Device Problems Failure to Align (2522); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 15sep2020.

Event Description

The field service engineer (fse) reported the unit failed to be operable on the screen and calibration.The unit was in clinical use; however no patient harm.The device continued to ventilate the patient and there was no report of medical intervention.The fse confirmed the reported failure.The fse identified misalignment in the touch position.The fse replaced the touchscreen then the issue was resolved.

Manufacturer Narrative

G4:10dec2020.B4:14dec2020.The touchscreen was returned to the manufacturer for failure investigation (fi) analysis.The resistance ratio were out of specification.Fault are found on this returned touchscreen.Based on information provided and/or service performed it has been confirmed unit did not meet product specifications.The device was being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.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: 10537495
• MDR Text Key: 208536622
• Report Number: 2031642-2020-03271
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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
• Treatment: UNKNOWN PATIENT CICUIT, MASK, AND HUMIDIFIER.