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

Model Number V60

Device Problems No Display/Image (1183); Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13jan2021.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.

Event Description

It was reported to philips that the device stopped operating and generated an alarm during use in the icu.Since the screen went off, the alarm that occurred was unable to be confirmed.The device was in use at the time of the event.The device was replaced with the same model.The patient was able to breath spontaneously, and there was neither delay in therapy nor other medical intervention reported other than the ventilator swap.

Manufacturer Narrative

G4:14jan2021.B4:18jan2021.The philips service technician evaluated the ventilator and an operational check was performed but the reported phenomenon was not confirmed.The error log was check and then the confirmed the occurrence of the pressure regulation high error.The philips service technician performed a pressure/flow accuracy test, but no issue was confirmed.As no abnormality was confirmed in the device, the data acquisition board which monitored the pressure was replaced for a preventive measure.The device successfully passed all required testing, and remains at the customer site.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: 24apr2021.B4: 27apr2021.Visual inspection of the data acquisition (daq) assembly found no anomalies noted.A failure investigation (fi) technician installed the daq into a fi ventilator to duplicate the reported issue.The daq system was installed into the fi test ventilator and an attempt to boot into the normal ventilation mode was made.No fault was found on the returned part.Fi investigation could not replicate problem.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: 11165664
• MDR Text Key: 227822878
• Report Number: 2031642-2021-00144
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2020

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: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/17/2020; 12/17/2020
• Supplement Dates FDA Received: 01/18/2021; 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• 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.