MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

V60 bipap machine failed while on patient.Alarm 'blower stalled" (non serviceable alarm) displayed on bipap screen.Patient was removed from the bipap immediately and placed on optiflow at 100% and 60 lpm until a replacement bipap was prepared for use.She was then placed on the replacement bipap which is functioning properly.She did not exhibit signs of distress or decompensation while on optiflow.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 14944120
• MDR Text Key: 295415128
• Report Number: 14944120
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/24/2022

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 Model Number: V60
• Device Catalogue Number: U1053617
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA