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

Model Number V60

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20aug2020.

Event Description

A customer reported to philips that a patient experienced an outcome of death while receiving therapy from the v60 ventilator, and that the ventilator did not generate an alarm.The customer reported that the device was in use on a patient at the time of the reported patient outcome and reported device behavior.

Manufacturer Narrative

G4: 04nov2020.B4: 04nov2020.A philips authorized representative evaluated the device, was unable to duplicate the symptom, and the nurse call system on device functioned without issues.No diagnostic report was available for review.This biomedical engineer reported that there was a problem with the hospital¿s nurse call system; non-philips product with details not provided, on the day of the reported event.The remote alarm (nurse call) port allows ventilator alarm conditions to be annunciated at locations away from the ventilator (for example, when the ventilator is in an isolation room).The ventilator sends alarm signals to a remote alarm through the connector at the rear of the ventilator.The connector is a standard ¼-inch, female, audio (ring, tip, sleeve) connector.To prevent possible patient injury due to non-annunciating alarms, the operator must verify the operation of any remote alarm device before use.To ensure the functionality of the remote alarm, the operator must connect only respironics approved cables to the remote alarm port (respironics v60 / v60 plus ventilator, user manual, publication number 1047358, revision u, september 2019, page b-19).No parts were replaced.The device passed all performance verification testing and remains at the authorized representative's bench repair site this risk manager reported a user facility medwatch report (mw5096217) 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.Relevant medical history included multiple comorbidities with diagnoses and diagnostic dates not reported.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator and a respironics bipap disposable circuit (312118) with lot number 200416 and expiration date 31mar2025.The ventilation prescription, device settings, configuration, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device, the device circuit became disconnected with the location not reported, the ventilator did not generate any alarms, no alarms were generated through the nurse call system, the patient experienced a cardiopulmonary arrest, cardiopulmonary resuscitation efforts were initiated and continued for 30 minutes, and the patient experienced an outcome of death.No relevant laboratory data was reported.There is no information to support that a malfunction occurred.Philips was unable to determine the cause of the reported symptom as it could not be reproduced, no diagnostic report was provided for review, and no error codes were reported.The available information provided for this safety report suggests that the hospital's non-philips central monitoring system not functioning as intended may have been a factor in this event.Failure investigation did not occur due to no parts were replaced.Therefore, the root cause of the reported issue could not be determined.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: 10432163
• MDR Text Key: 203700666
• Report Number: 2031642-2020-02859
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death