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

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

Nurse noticed that the screen of bipap was "going black" and shutting off while patient was using equipment.Rn unplugged and re-plugged device in - device turned back on to original settings.Out of caution, the machine was pulled from service and replaced with a new unit.

• Brand Name: RESPIRONICS V60
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 16014757
• MDR Text Key: 305874727
• Report Number: 16014757
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: Black Or African American