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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 06dec2020.

Event Description

The customer reported it was impossible to operate the touch panel of the screen.It was impossible to operate the tabs on the bottom of the screen (setting-change tab/alarm-setting tab).The doctor reported that a failure was observed in the screen.The device kept operating.The unit was in clinical use, but there was no patient harm.

Manufacturer Narrative

G4:03dec2020.B4: (b)(6) 2021.The field service engineer (fse) confirmed the reported issue by an operational check performed.Calibration was performed but did not resolve the issue.The (fse) replaced the touchscreen, and the issue was addressed.The unit was tested and was returned to service.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

G4:21apr2021.B4:26apr2021.D4: udi: (b)(4).The touchscreen was returned to manufacturer to failure investigation (fi) for analysis.Electrical testing are out of specification.Customers complaint verified "s/t settings" and "alarm settings" intermittently failed.Fault is found on this returned touchscreen assembly.This failure was caused by the manufacturing process leaving dead spots on the screen, 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: 10956346
• MDR Text Key: 220442864
• Report Number: 2031642-2020-04411
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• 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: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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 CIRCUIT, MASK, AND HUMIDIFIER