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

Model Number V60

Device Problems Break (1069); Poor Quality Image (1408); Component Missing (2306); Inadequate User Interface (2958); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of this report: 05 jun 2020.

Event Description

The customer reported high priority alarms when powering on the unit.The customer found error codes in the significant even logs.The customer also indicated the unit's touchscreen froze.The service technician confirmed the reported complaint.The unit showed a 35 volt failure error, so the power management printed circuit board assembly needed to be replaced.The liquid crystal display was very dark and needed replacement.The top cover was also broken and needed replacement, along with the rear bezel.The rear bezel, avaps (average volume assured pressure support) label, c-flex label, battery label, and positive pressure ventilation label will need replacement.The power cord retainer was missing and needs replacement.There was no patient involvement and the unit was not in use at the time of the reported problem.

Manufacturer Narrative

G4:04feb2021.B4:05feb2021.The power management (pm) printed circuit board assembly (pcba) was returned for analysis.Visual inspection of the power management (pm) pcba revealed no evidence of damage or contamination.An investigation was performed and the r31 solder crack open not making contact with the trace on the pm pcba created the following error: blower stalled, 35v supply failed , auxiliary alarm supply failed, patient circuit occluded alarm message and backup alarm failed.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: 10125969
• MDR Text Key: 194770739
• Report Number: 2031642-2020-01993
• 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
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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