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

Model Number V60

Device Problem Intermittent Loss of Power (4016)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

Registered respiratory therapist was placing mask on patient and the bipap v60 ventilator shut down and then powered back up.No harm to patient.

Event Description

Registered respiratory therapist was placing mask on patient and the bipap v60 ventilator shut down and then powered back up.No harm to patient.

• 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: 15751779
• MDR Text Key: 303259695
• Report Number: 15751779
• 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,Followup
• Report Date: 10/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2022
• Date Report to Manufacturer: 11/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA