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

Model Number V60 PLUS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 19jan2021.

Event Description

The customer reported a ventilator was giving pressure incorrect pressure measurements.The device was reported to be in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4:03mar2021.B4:04mar2021.H11:g5:k102985.H10:the device was evaluated by an international philips field service engineer (fse) who could not duplicate or verify the reported issue.The fse serviced the device and could not verify the reported problem.The device was reported to have no problems and correct pressures.The customer was reminded that it is always necessary to check the connections between the patient and the equipment so that there are no excessive leaks by the mask or circuit.Operational, functional, and safety tests were conducted and found to comply with factory settings.No other anomalies were reported.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: 11195150
• MDR Text Key: 231155778
• Report Number: 2031642-2021-00197
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• 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