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

Model Number V60

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06oct2020.

Event Description

It was reported that the unit was ventilating a patient when the display turned off though air flow continued.The unit was providing therapy to a patient, and therapy continued and the patient remained unharmed.

Manufacturer Narrative

G4: 06oct2020.B4: 08oct2020.The reported phenomenon was not duplicated.The cable and ui ground was replaced for the prevention of the recurrence.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: 13oct2020.B4: 12nov2020.Additional issues found by the field service engineer (fse) while servicing the ventilator includes primary alarm failed, the power light emitting diode (led) had illumination failure, and the oxygen concentration was out of allowable range.The fse replaced the speaker, the power switch overlay, and the flow sensor assembly and the issues were 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.

Manufacturer Narrative

G4: 15oct2020 b4: (b)(6)2020 the field service engineer (fse) evaluated the device and found additional issues aside from the reported phenomenon.Additionally, the fse confirmed the occurrence of 3.3v supply failure, 5v supply failure, 35v supply failure, motor controller printed circuit board analog to digital converted, and over voltage protection circuit failed.In order to resolve the issues, the fse replaced the power management printed circuit board assembly, the motor controller printed circuit board assembly.The unit was checked overall, cleaned, and functionally tested.It was confirmed the issues were resolved with the replacement parts.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:(b)(6) 2020.B4:(b)(6) 2021.The power management board and motor controller board were received for failure investigation.The power management board was tested and no faults were found.During testing of the motor controller using the dac-adc wrap feature of v60 diagnostic mode, we found that the dac output was present but acd code did not represent input value.Replacement of acd u6 corrected problem.Unit performed normally after repair.Customer complaint verified.Root cause is failure of ic u6.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: 10635376
• MDR Text Key: 212306654
• Report Number: 2031642-2020-03574
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER