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) 2020.Date of report: 20oct2020.

Event Description

The customer reported error blower temperature high.There was no patient involvement.

Manufacturer Narrative

G4:04nov2021.B4:03mar2021.H11:g5:k102985.H10: the manufacturer's field support engineer (fse) evaluated the unit and confirmed the reported error code in the diagnostic log.Air inlet was found to be clean and not blocked.Fse confirmed fan was operational.Fse recommended blower replacement due to error code.The fse replaced the unit's blower to resolve the reported issue.Unit passed required performance verification tests per philips standards.G4:06feb2021.B4:03mar2021.The blower was returned to the manufacturer for failure investigation.After testing, the customer's reported complaint could not be verified.The returned blower passed all testing, and no-fault was found.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: 10708393
• MDR Text Key: 213682857
• Report Number: 2031642-2020-03782
• 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: 09/29/2020

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: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2016
• 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