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

Model Number V60

Device Problems Detachment of Device or Device Component (2907); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 30nov2020.

Event Description

The customer reported the error for patient disconnect was noted though the device did not alarm and the touchscreen froze.The patient's mask was not connected.Therapy continued without interruption and without medical intervention.There was no patient/user harm reported.The manufacturer's sales representative was unable to find an error in the log as well as was unable to duplicate the reported issue.

Manufacturer Narrative

G4:07jan2021.B4:12jan2021.H11: h6: no patient involvement.H10 the reported issue was not confirmed by an operational check performed by the field service engineer (fse).No error indicating a device failure was recorded in the diagnostic error log.Regarding the alarm not sounding at the time of release issue, no abnormality was confirmed by operational check or functional test.The error log shows the patient disconnect alert did display as expected and designed as well as the alarm sounded; however, the user-selected alarm volume was very low.Therefore it has been determined that there is no issue in the unit.It is assumed that an external factor caused the issue.A check performed by the fse confirmed misalignment in the touch position.Since it is possible that the screen temporarily froze due to a touchscreen failure, the touchscreen was replaced by the fse.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

G4:12feb2021.B4:15feb2021.It was clarified that the device was in use with a patient at the time of the issue.The patient was swapped to a different ventilator, and no additional patient harm was reported.The error log shows the user-selected alarm volume was at level 8.Based on the information provided and/or service performed, the customer's alleged patient disconnect alert without an alarm was not confirmed.The root cause is unable to be determined.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

The touchscreen assembly was returned for failure investigation.Visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.The reported issue of touchscreen failing was not confirmed.No failures were identified in the returned touchscreen, and it met all specifications.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10923980
• MDR Text Key: 219182760
• Report Number: 2031642-2020-04300
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• 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
• Report Date: 07/26/2021

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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 11/04/2020; 06/11/2021
• Supplement Dates FDA Received: 01/13/2021; 02/15/2021; 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2018
• 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; UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER