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

Model Number V60

Device Problems Unintended Power Up (1162); Battery Problem (2885); Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21oct2020.

Event Description

The medical engineer reported "battery failed" alarm occurred.The medical engineer confirmed the battery failed" alarm occurred during pre use checking for the device, which was prepared as an alternative device of repair.The unit was sent to the repair center and occurrence of "internal battery failed" diagnostic code was confirmed in the repair center and occurrence record of the error was also confirmed in the drpt (diagnostic log).The repair center confirmed that the output voltage of lithium-ion battery was zero volts.The lithium-ion battery (pn:1076374, lot:m84728p1, date of manufacture:2019-04-30) needs to be replaced.The repair center also confirmed the occurrence record of "machine pressure sensor auto-zero failed" diagnostic code was confirmed in the drpt.Data acquisition (da) board (pn:1054356, sn:(b)(6)) needs to be replaced.The repair center also confirmed an issue that the unit starts up on its own was confirmed.The user interface board 2ndgen (pn:1100786, sn: to be indicated at replacement) needs to be replaced.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

G4:11jan2021.B4:13jan2021.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

D4:udi#: (b)(4).The service engineer confirmed replacing the lithium-ion battery resolved internal battery failure.Since an occurrence record(s) of diagnostic code consistent with machine pressure sensor auto-zero failed was confirmed in the diagnostic report, the data acquisition board was replaced to resolve the issue.The user interface board was replaced to resolve the issue of the unit starting up on its own.The fan guard was missing and was attached.Following the repair, the device was returned to the customer to be placed back into 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10715286
• MDR Text Key: 214800132
• Report Number: 2031642-2020-03799
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2017
• 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