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

Model Number V60

Device Problems No Display/Image (1183); Defective Device (2588); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

V60 bipap (bilevel positive airway pressure) equipment failure while in use.Bipap turned off, black screen appeared, alarm sounded, screen stated that machine was inoperable.Nurses responded to alarms and placed patient on nrb (non-rebreather mask) until i arrived.Nurses stated that patient saturations were in the 30s.She was grey when i got there about 1 minute later, but responsive and sating in 70s.Machine was turned off and turned back on, placed patient on bipap until new unit arrived.Patient was able to recover on bipap.She is now on another unit, work order placed for malfunctioning unit.

• Brand Name: V60 VENTILATOR
• 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: 13794801
• MDR Text Key: 287332419
• Report Number: 13794801
• 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: 03/09/2022

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: 1053617
• 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: 03/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18250 DA
• Patient Sex: Female
• Patient Race: White