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

Model Number V60

Device Problem Defective Component (2292)

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

It was reported to philips that the device had a alarm led (light emitting diode) failure.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.

Manufacturer Narrative

G4:28dec2020.B4:29dec2020.The philips service engineer (se) evaluated the ventilator and was the reported issue unable to be reproduced.The error log revealed that error 1105 (alarm led failed) had occurred.In addition, an illumination failure of the power led was observed, noise coming from the blower along with a cracked top cover.Additional cases have been opened for these observances.The se replaced the power switch overlay to resolve the issue.The device successfully passed all required testing.A similar investigation was performed it was identified that excessive engagement or pressure contact over the light emitting diode (led) while attempting to engage the switch do to the proximity of the led to the switch may cause a separation of the led to the encapsulant.This is subjective to the operator of the equipment which is why this is not a universal or catastrophic failure of all units.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: 10708800
• MDR Text Key: 213668383
• Report Number: 2031642-2020-03790
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• 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: 09/30/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2011
• 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