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

Model Number V60

Device Problems Failure to Align (2522); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28dec2020.

Event Description

The customer reported while attempting to perform a pre-use check prior to being put into service.The screen did not react to touch.The incident happened prior to being put into use.There was no patient involvement or delay in treatment.No patient/user harm was reported.The field service engineer (fse) confirmed misalignment in the touch position reported failure.The issue was not resolved by calibrating the touchscreen; therefore, the touchscreen was replaced.

Manufacturer Narrative

G4:20apr2021.B4:26apr2021.The touchscreen was returned to manufacturer for failure investigation analysis.The reported complaint touchscreen failed is not duplicated.There is no fault found on this returned touchscreen assembly.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: 11084650
• MDR Text Key: 225276980
• Report Number: 2031642-2020-04756
• 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
• Report Date: 11/30/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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