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

Model Number V60

Device Problem Device Alarm System (1012)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

The patient was on a bi-level positive airway pressure (bipap).The bipap did not alarm when the patient took it off.The patient managed to scoot down the bed and fell.Patient suffered subdural hematoma and had to be transferred to higher level of care.

• 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: 13710125
• MDR Text Key: 286855588
• Report Number: 13710125
• 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: 02/28/2022

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: 02/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA