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

Model Number V60

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 29jan2021.

Event Description

It was reported to philips that the device displayed a high internal heat alarm.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer (biomed) with assistance from a philips remote service engineer (rse).The biomed stated that cbit temp high blower was found in the significant event logs.The rse referenced the service manual instructions for the boomed to; 1.Verify that the air inlet filter is not dirty or blocked; verify that the cooling fan is operational; replace the blower; replace the mc pcba.

Manufacturer Narrative

G4:03feb2021.B4:10feb2021.The device was in use at the time of the event.The patient was placed on another v60 with no other medical intervention required besides the ventilator swap.There was no report of patient or user harm.A good faith effort was made and the customer stated that the filters were changed and testing was completed on a test lung.The device passed testing and was placed back in service.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: 11254783
• MDR Text Key: 230547835
• Report Number: 2031642-2021-00366
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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