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

Model Number V60

Device Problem Failure to Deliver (2338)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 27aug2020.

Event Description

A customer reported to philips that the respironics v60 ventilator generated a ¿blower stalled¿ alarm while delivering therapy to a patient, and the patient experienced an event of decreased peripheral capillary oxygen saturation (spo2).The customer reported that the unit was in use on a patient at the time of the reported device behavior and adverse event.

Manufacturer Narrative

G4: 04nov2020.B4: 04nov2020.Review of the provided diagnostic report from 20aug2020, showed multiple blower stalled, auxiliary alarm supply failed, 35 volt supply failed, backup alarm failed, ventilator restarted due to anomalies detected during operation.This was a malfunction of the power management pcba.No parts were returned for failure investigation.Therefore, the root cause at the component level 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.

Manufacturer Narrative

G4: 02oct2020.B4: (b)(6) 2020.A philips field service engineer (fse) evaluated the device and the reported issue was confirmed.The error codes were confirmed via the device event log.The fse replaced the power management pcba.The device passed all performance verification 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.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device with software version 2.30, the device generated a ¿blower stalled¿ alarm, the patient experienced an event of decreased peripheral capillary oxygen saturation (spo2) with values not reported, and hospital staff provided ventilation therapy with details not reported.No relevant laboratory data was reported.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: 10462778
• MDR Text Key: 204679016
• Report Number: 2031642-2020-02988
• 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,Followup
• Report Date: 08/20/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/20/2020; 08/20/2020
• Supplement Dates FDA Received: 10/05/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER