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

Model Number V60

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21sep2020.

Event Description

The hospital medical engineer reported that the device annunciated an alarm to indicate the backup alarm had failed.The device was in clinical use when the alarm annunciated.It was immediately replaced with a backup device.There was no patient harm and no change in the patient's condition.The device error log confirmed the event, but the local representative could not duplicate the event.Investigation is still ongoing.

Manufacturer Narrative

G4: 28dec2020 b4: (b)(6) 2021 the field service engineer replaced the cpu pcba (central processing unit, printed circuit board assembly) board as a precaution.The ventilator was calibrated successfully and passed all required testing.A cpu pcba (central processing unit, printed circuit board assembly) was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the root cause was isolated to a failure of the ls1 component.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: 10564226
• MDR Text Key: 208601245
• Report Number: 2031642-2020-03380
• 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
• Report Date: 09/02/2020

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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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