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

Model Number V60

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01oct2020.

Event Description

The customer called into technical support (ts) reporting that the device did not shift to standby mode, noise like a cough was heard in the operation sound and the displayed ventilation volume became high.The device was in patient use at the time the reported issue was discovered; however, there was no harm to the patient or user.The customer reported no delay in patient therapy nor medical intervention required.The unit kept operating when the reported event occurred.

Manufacturer Narrative

G4:08oct2020.B4:02apr2021.The operation of the unit was tested, but the reported phenomenon could not be duplicated.Performed a functional test but no abnormality was confirmed.The unit was checked overall, cleaned, and run in tests.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

G4:14sep2020.B4:12apr2021.The device was in patient use at the time the reported issue was discovered.The displayed ventilation volume became high, so they replaced the unit with the same model.There was no harm to the patient or user.The customer reported no delay in patient therapy or medical intervention required.The unit kept operating when the reported event occurred.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

G4:21apr2021.B4:26apr2021.Review of the device event log reveals the occurrence of o2 unavailable and low o2 supply pressure alarms on the date of incident.It was confirmed that the unit was running on wall oxygen at the time of the event.The failure of going into standby mode and the reported noise could have been caused by the low oxygen supply pressure.The unit was evaluated by the philips service engineer (se) and the reported problems could not be duplicated.No faults were found with the unit.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: 10617465
• MDR Text Key: 209603372
• Report Number: 2031642-2020-03542
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2020

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 09/14/2020; 09/14/2020
• Supplement Dates FDA Received: 04/02/2021; 04/12/2021; 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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