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

Model Number V60

Device Problems Defective Alarm (1014); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29dec2020.

Event Description

It was reported to philips light emitting diode (led) alarm failed inoperable (inop) being displayed.Diagnostic code consistent with led alarm failure was present.The remote service engineer (rse) provided the biomed with service exchange part number for power switch overlay power management board, switch printed circuit board assembly, cable to power management and price so they can order direct and install themselves and biomed also provided with fixed price repair details.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

G4:15mar2021.B4:16mar2021.Diagnostic code consistent with led alarm failure was present.The remote service engineer (rse) provided the biomed with the service exchange part number for power switch overlay, power management board, switch printed circuit board assembly, cable to power management, and price to order directly and install themselves.The biomed was also provided the fixed price repair details.The customer was provided with the parts required, but as the device is no longer under contract, it is up to the customer if/when they carry out the repair.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: 11092149
• MDR Text Key: 225304521
• Report Number: 2031642-2020-04792
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2009
• 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