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

Model Number V60

Device Problem Failure to Read Input Signal (1581)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03sep2020.

Event Description

It was reported to philips that the ipap (inspiratory positive airway pressure) failed to increase up to the set pressure.The displayed ipap value was 10 cmh2o against 12 cmh2o of the set value.The device was being used on the patient, but it was replaced with another one as a precaution.There was no medical intervention or delay to patient therapy, and another v60 ventilator was put on the patient as a result of the event.A philips authorized service personnel (asp) was dispatched to the customer site and confirmed that the data acquisition pcba had a failure and required replacement.

Manufacturer Narrative

G4:21dec2020 b4:(b)(6)2020 the data acquisition (assy,pcb,data acq, v8000) was returned for evaluation.Visual inspection revealed no signs of anomalies.A failure investigation (fi) technician installed the data acquisition pcba into a fi ventilator to duplicate the reported issue.During the unit testing the fi technician confirmed the customer complaint with the root cause being a failure of pressure sensor u7.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: 09oct2020; b4: 13oct2020.The data acquisition pcba was replaced which resolved the reported issue.The device passed all required testing and returned to full functionality.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: 10491274
• MDR Text Key: 206767103
• Report Number: 2031642-2020-03143
• 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,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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.