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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 12/31/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 11jan2021.

Event Description

It was reported to philips that while in therapeutic use, the v60 ventilator displayed error code - oxygen not available at 0812 local time of the facility.At 1653 local time of the facility, the patient was noted to have expired.The device was in clinical use and providing therapy during the time of the event.The device notification of the oxygen not available error code was noted to have been identified by the facility nursing staff and reported to in house facility medical engineers.The patient subsequently expired approximately 8 hours and 41 minutes after the noted alarm triggered.

Manufacturer Narrative

G4:( b)(6) 2021 b4:( b)(6) 2021 the device was retrieved and inspected by a philips authorized field service engineer (fse).The unit was connected to a compressed gas oxygen cylinder (unknown size) with a pressure delivery of 45 pounds per square inch (psi).A breathing circuit (unknown make/model) was used for testing.The device diagnostic report (drpt) was obtained and reviewed.Testing with the device evaluation setup did not yield any duplication of the alleged complaint.Drpt review prior to, during, and after the alleged event time frames found no occurrence of device malfunction with alarm error code 1208(oxygen not available) triggering effectively in response to non-device generated oxygen flow issues.The fse performed the following testing with success and no abnormalities confirmed: high pressure leak, pressure accuracy, air and oxygen flow, oxygen concentration.After thorough investigation and device inspection, the device did not fail to meet design specifications and no malfunction was found.Supplemental oxygen delivery error codes generated by the device functioned as designed and intended to alert the user of the condition state caused by external oxygen supply failure.During this condition, the device provided a high priority audible and visual alarm, which was acknowledged by the facility clinical and medical engineering staff.As per the v60 user manual rev k.Corrective actions recommended are as follows under this condition state: check the patient, check if high/low o2 source is the problem and correct, if problem persists, provide alternative ventilation, have ventilator serviced.Based upon this information, it can be determined that due to external/non-device related compromised oxygen source failure, there is not a causal or contributory relationship of the patient death to the device.Device related root cause is not applicable based upon no findings of failure or malfunction.Serious adverse event root cause can be attributed to use error.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
• MDR Report Key: 11151964
• MDR Text Key: 226215270
• Report Number: 2031642-2021-00111
• 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: 01/07/2021

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: 01/07/2021
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death