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

Model Number V60

Device Problems Defective Alarm (1014); Insufficient Flow or Under Infusion (2182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13aug2020.

Event Description

A customer reported to philips that the v60 ventilator the device did not generate a ¿patient disconnect¿ alarm and the patient experienced an event of decreased oxygen saturation.The customer reported that the unit was in use on the patient at the time of the reported device behavior and adverse event.The patient was placed on another v60 ventilator, and therapy was continued.

Manufacturer Narrative

G4: 04sep2020, b4: 08sep2020.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.The software version on the device was confirmed to be 2.30.No parts were replaced.The device was cleaned, passed all performance assurance tests, and was placed back into use with the customer.This reporter stated that a 90 years old male patient with unknown 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 intubated; endotracheal tube brand, model, and size not reported, and prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, and patient circuit.While admitted on 04aug2020, the patient was receiving therapy via the v60 device, the device became disconnected from the patient, did not generate a ¿patient disconnect¿ alarm, the patient experienced an event of decreased peripheral capillary oxygen saturation to 80 percent, the patient¿s nurse was alerted to the hazardous situation via a biometric alarm monitor; brand and model not reported, and the patient was placed on another v60 ventilator.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 further investigation or action is warranted.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: 10405120
• MDR Text Key: 202876404
• Report Number: 2031642-2020-02770
• 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: 08/05/2020

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: 08/05/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Life Threatening
• Patient Age: 90 YR