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

Model Number V60

Device Problems No Audible Alarm (1019); Disconnection (1171)

Patient Problem Death (1802)

Event Date 02/05/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 17feb2020.

Event Description

While in use and providing therapy to the patient, remote monitoring of spo2 via nurses station showed marked decrease, prompting the nurse to perform assessment of patient.Upon arrival, the nurse discovered a circuit disconnection at circuit and mask connection.The nurse states no alarms were present or had occurred.Patient sentinel event.

Manufacturer Narrative

G4: 08jun2020.B4: 17jul2020.A repair bench technician evaluated the device and performed a check on the unit based on the check sheet provided by the manufacturer and confirmed there was no abnormality with the device.The device event logs/error logs (drpt) are not available for review.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date, with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.During the admission on an unknown date, the patient had spontaneous respirations and was prescribed ventilation therapy via the respironics v60 ventilator, with patient circuit 1137263 vision heated humidifier disposable circuit, product number 1136818, and face mask 1079078 af811 gel full face, size m, product number 1063052.The ventilator settings were reported as default settings, with the alarm volume set to 5 with the alarm volume escalation feature not in use.While admitted, on 05feb2020, the patient was receiving therapy from the v60 and a circuit disconnection at circuit and mask connection occurred, the patient experienced an event of decreased peripheral capillary oxygen saturation (spo2); results not reported, which was being monitored remotely at the nurses¿ station, the device did not generate any audible or visual alarms, and the patient experienced an outcome of death.The cause of death was not reported.It is unknown if the patient was connected to another ventilator, it is unknown if the patient¿s therapy was changed to invasive positive pressure ventilation (ippv), it is unknown if any rescue efforts were administered.No relevant laboratory data was reported.The repair bench was not able to confirm the reported device behavior.The cause cannot be determined because the problem could not be recreated.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9717088
• MDR Text Key: 179696219
• Report Number: 2031642-2020-00522
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death