MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V680 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK

Model Number V680

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

Patient Problem Insufficient Information (4580)

Event Date 12/20/2020

Event Type  Injury  

Manufacturer Narrative

Event date: (b)(6) 2020.Report date: 29dec2020.

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v680 ventilator became disconnected from the patient, did not generate an alarm, and the patient required manual ventilation.The customer reported that the unit was in use on a patient at the time of the reported device behavior and medical intervention.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 v680 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020 at approximately 1000, the patient was receiving therapy via the v680 device, the patient became disconnected from the device, the device did not generate any audible alarms, hospital staff administered manual ventilation, and the patient was then reconnected to the v680 ventilator.No relevant laboratory data was reported.Post event, the hospital's biomedical engineer reviewed the device's diagnostic report (drpt), and reported that the device generated several patient disconnect alarms during the event.No adverse event was reported or associated with the use of this device.

Manufacturer Narrative

B3: 30dec2020.B4: 30dec2020.Correction: the v680 is an exported device and not available for commercial distribution in the united states, therefore does not fall within fda reporting guidelines.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: V680 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11091306
• MDR Text Key: 224333947
• Report Number: 2031642-2020-04772
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00884838053595
• UDI-Public: (01)00884838053595
• Combination Product (y/n): N
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V680
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Required Intervention