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: 20nov2020.

Event Description

The customer reported primary alarm failure.There was no patient involvement.

Manufacturer Narrative

G4:12jan2021.B4:13jan2021.The manufacturer¿s international service technician confirmed the reported issue.Confirmed in the error record that there had been a failure in the speaker connected to the power management board and it had been causing primary alarm failed.In addition, it was also confirmed that the speaker on the power management board side was not sounding.The manufacturer¿s international service technician replaced the defective speaker to address the reported problem.The unit successfully passed the required performance verification test.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

The electrical open in the speaker created the primary alarm failure error code.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10880969
• MDR Text Key: 218658476
• Report Number: 2031642-2020-04216
• 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: 08/11/2021

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/21/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 10/28/2020
• Supplement Dates FDA Received: 01/13/2021; 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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