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

Model Number V60

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 06/09/2021

Event Type  Injury  

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator became disconnected from the patient circuit, and the patient experienced an event of cardiopulmonary arrest.The customer reported that the unit was in use on a patient a the time of the device behavior and adverse event.No further information regarding device evaluation and inspection was provided by the reporter.No device service or evaluation by philips was requested by the reporter.Based upon further investigation into the complaint record, the patient experienced an event of cardiopulmonary arrest due to an unintentional use error of breathing circuit disconnection during therapeutic delivery.Upon initiation of life-saving medical intervention, the patient was subsequently intubated and placed onto a mechanical ventilator.On an unknown date after the event in question, the patient expired.No cause of death was provided to philips.It was noted by the reporter that the device provided appropriate audible and visual alarms in order to alert the clinical end-user of the patient's disconnection.Assessment of this complaint record has determined no causal relationship of the v60 ventilator to the patient serious injury incurred, however, due to the unintentional use error of the breathing circuit disconnection during therapeutic delivery, the contribution of the ventilator device use has been confirmed.The root cause has been determined to be unintentional use error.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14163614
• MDR Text Key: 289698183
• Report Number: 2031642-2022-01051
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention