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

Model Number V60

Device Problem Failure to Align (2522)

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

The customer reported that the volume numbers do not line up correctly with exhaled volume.The customer contacted product support and also reported that several errors in the significant event logs.The product support advised the caller of the suspect data acquisition board and maybe the data acquisition to motor controller board cable per service manual rev k.Product support provided part id for both 453561512561 rp-pcba, data acquisition cable, da pcba to mc pcba (2nd generation).The customer reported that the unit was not in use on a patient.The issue was discovered during pre-use check for patient.

Manufacturer Narrative

G4:20jan2021; b4:22jan2021.The customer reported several errors in the significant log that indicates serial peripheral interface bus (spi bus) issue.The biomedical engineer reported the replacement of the gas delivery system (gds) to address the issue.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) 2021.B4: (b)(6) 2021.The biomedical engineer reported that the problem was discovered during annual maintenance when unit did not pass testing.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: 10738157
• MDR Text Key: 214800149
• Report Number: 2031642-2020-03859
• 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
• Report Date: 10/05/2020

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: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/05/2020
• Supplement Dates FDA Received: 01/23/2021; 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2009
• 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