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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 26oct2020.

Event Description

It was reported the end user got an error proximal pressure sensor auto zero failed.The device was in use at the time of the issue.The end user continued to use the unit on the patient and there was no harm reported.The error was also confirmed in the significant error log.The field service engineer (fse) provided remote support to the customer.It was determined that the day prior to the issue, the customer removed the data acquisition board during preventative maintenance in order to put some krytox on the o-ring.The unit passed performance verification testing (pvt) after that.The fse advised the customer to replace solenoids 3 and 4 as a precaution and if the error comes back then replace the data acquisition board.The customer reported unit failing pressure sensor test after running unit for 15 minutes.

Manufacturer Narrative

G4:07jan2021.B4:07jan2021.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

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

G4:27jan2021.B4:30jan2021.The field service engineer (fse) found the data acquisition (da) board installed incorrectly.None of the solenoid pins were inserted in to board.The fse reseated the da board properly and the issue was resolved.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: 10736597
• MDR Text Key: 214611961
• Report Number: 2031642-2020-03849
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/02/2020; 10/02/2020; 10/02/2020
• Supplement Dates FDA Received: 01/07/2021; 01/07/2021; 01/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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