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

Model Number V60

Device Problem Failure to Zero (1683)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 26jun2020.

Event Description

The customer reported receiving error check vent proximal sensor auto zero failed.The device was in use with a patient at the time of the issue, and the vent was swapped out.No patient harm was reported.The manufacturer's field service engineer (fse) confirmed tested the unit and the same error message appeared.

Manufacturer Narrative

G4:21dec2020 b4:(b)(6) 2020 a2: dob: (b)(6) 1968 a3: sex: male h11 the v60 gave check ventilator proximal sensor failed message, a circuit test was done and failed so the ventilator was swapped.The device was evaluated by an fse and the issue was confirmed.The fse replaced the flow sensor assembly.The device failed to meet specifications when it failed to operate while in use with a patient, though there was no patient harm.The device was being used for treatment when the reported event occurred.Due to the malfunction, the patient was removed from the device and there is a relationship of the device to the event.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

G4:21dec2020 b4: (b)(6) 2020 a2: dob: (b)(6) 1968 a3: sex: male the v60 gave check ventilator proximal sensor failed message, a circuit test was done and failed.The device was evaluated by an field service engineer and the issue was confirmed.The fse replaced the flow sensor assembly.The device failed to meet specifications when it failed to operate while in use with a patient, though there was no patient harm.The device was being used for treatment when the reported event occurred.Due to the malfunction, the patient was removed from the device and there is a relationship of the device to the event.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: 06nov2020.B4: 06nov2020.The field service engineer replaced the flow sensor assembly and the issue was 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: 01apr2021.B4: 03apr2021.The contamination inside the solenoid (4) created the error code.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: 10202587
• MDR Text Key: 197107728
• Report Number: 2031642-2020-02197
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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
• Patient Age: 51 YR