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

Model Number V60 PLUS

Device Problems Failure to Zero (1683); 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) 2021.Date of report: 04mar2021.

Event Description

The customer reported check vent machine pressure is alarming auto zero failure.The unit was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Based on information received, it has been identified that mfr report # 2031642-2020-04791 is the correct mdr and is the primary complaint.The report that has been identified to be the duplicate is the mdr report #2031642-2021-00846 and should be nulled.

Event Description

O2 flow accuracy test failed during service.

Manufacturer Narrative

B5: o2 flow accuracy test failed during service.Mfr# 2031642-2021-00846 is not a duplicate of mr# 2031642-2020-04791, as previously reported.The issue reported on mfr# 2031642-2021-00846 was found while servicing and testing the unit, and it's not a reportable event.A philips field service engineer (fse) was dispatched to the customer site, and during o2 flow accuracy testing, the gds began making a pulsing sound and failed at the 140slpm point.The fse determined that the gas delivery system (gds) needed to be replaced to return the device to working condition.The fse replaced the gas delivery system (gds) to resolve the reported issue.The device passed performance verification testing.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11418544
• MDR Text Key: 242581249
• Report Number: 2031642-2021-00846
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838090996
• UDI-Public: (01)00884838090996
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2021

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: No Information
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 06/30/2021; 07/29/2021
• Supplement Dates FDA Received: 07/28/2021; 07/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• 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