MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC PHILIPS RESPIRONICS V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY

Model Number V60

Device Problem Nonstandard Device (1420)

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

Event Date 08/19/2020

Event Type  malfunction  

Event Description

On march 2020, we received recall letter entitled "philips v60 ventilators may shut down unexpectedly due to a premature component failure." we notified philips that we had four affected v60 ventilators that required replacement of the power management pcba part.In april, philips send a second letter in regards to the "philips v60 ventilators may shut down unexpectedly due to a premature component failure" informing us that due to covid-19 they are experiencing a delay in the production of the components necessary to correct/repair the ventilators.This facility did not remove any of the four devices from service per philips original analysis that concluded it is not necessary to remove affected philips v60s from service due to the rarity of the failure.Philips maintained that the public health is best protected by leaving non-failed v60s in the field for critical lift-sustaining therapeutic use.Biomed follow up: biomed requested a service person to come to facility and repair this vent.Philips has indicated that they will remediate the recall on the vent at that time.Philips explained that they do not have the inventory of parts to remediate all of our vents affected, but because this one failed relative to the recall, they will repair it.

• Brand Name: PHILIPS RESPIRONICS V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 10520509
• MDR Text Key: 206519902
• Report Number: 10520509
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020,08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2020
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1