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

Model Number V60

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 17jun2020.

Event Description

The manufacturer's field service engineer reported a ventilator that failed electrical safety and leak testing.There was no patient involvement.

Manufacturer Narrative

G4: 21oct2020 b4: (b)(6) 2020 the device was not in use at the time of the event.This issue occurred during testing.The customer requested the device be sent to the philips bench repair for evaluation and repairs.The philips bench technician evaluated the device and could not duplicate the reported complaint.The bench technician performed many high pressure and system leak tests and all passed.The bench technician recommended the customer check oxygen hoses at site.The bench technician also performed the electrical safety testing and the unit passes.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

G4:05feb2021.B4:08feb2021.A power cord (3 wire, rt angle, na, 10a) was returned for evaluation.Visual inspection of power cord revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the power cord into a fi ventilator to duplicate the reported issue.The power cord resistance was measured between each connectors and flexing the cable during the measurement.The power cord ground resistance was found to be out of specification.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: 10165014
• MDR Text Key: 195898999
• Report Number: 2031642-2020-02113
• 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,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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