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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of event: (b)(6) 2020.

Event Description

A user facility stated via a medwatch 3500a report, that a respironics v60 ventilator stalled while providing bipap therapy to a patient and the patient experienced an event of oxygen desaturation.The device was in use on a patient at the time of the reported device behavior and the patient experienced an event of oxygen desaturation.

Manufacturer Narrative

G4: 10nov2020.B4: 10nov2020.H1: h6: patient code: updated to death.This patient with a height of 145 centimeters (cm), was admitted to a hospital on (b)(6) 2020, with an admitting diagnosis of fever and chills.On (b)(6) 2020, the patient experienced an outcome of death, with the primary and secondary cause not reported.It is unknown if the patient was receiving ventilation therapy via the v60 ventilator at the time of the reported outcome.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: 03nov2020.B4: (b)(6) 2020.The hospital's biomedical engineer evaluated the device and was unable to duplicate the symptom.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.Philips is unable to confirm the customer¿s allegation since there was no technical support requested.No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.This user facility reported via medwatch 3500a report number (b)(4), that a female patient born (b)(6) 1939, weighing 70.6 kilograms, with height not reported, was admitted to the hospital on a date not reported, with an 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 bilevel positive airway pressure (bipap) therapy via the respironics v60 ventilator; device settings, configuration, and patient circuit brand, model, lot number, and expiration date not reported.While admitted on (b)(6) 2020, the ventilator generated a visual alarm of ¿blower stalled¿ and the touch screen ¿was not responding to commands¿, the device was not ventilating the patient in bipap mode, the patient experienced an event of peripheral capillary oxygen saturation (spo2) in the 50s, hospital staff removed the bipap device from the patient, and administered 100% oxygen via a nonrebreather mask; brand, model, lot number, and expiration date not reported.The patient event of oxygen desaturation resolved within 20 to 30 minutes of medical intervention, with spo2 in the 90s.As of (b)(6) 2020, the patient remains admitted in an intermediate medical care unit receiving bipap therapy.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 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

Further information received has determined that the patient expiration was not related the alleged device malfunction, nor as cause or contribution to the patient outcome been found.The previous status of fda mdr - death is thereby being redacted and downgraded to serious injury due patient decrease in saturation of peripheral oxygenation and subsequent provision of medical intervention via a non-rebreather mask.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10323339
• MDR Text Key: 200379327
• Report Number: 2031642-2020-02482
• 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,Followup
• Report Date: 06/23/2021

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: 07/15/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/15/2020; 07/15/2020; 06/23/2021
• Supplement Dates FDA Received: 11/04/2020; 11/10/2020; 06/23/2021
• Was Device Evaluated by Manufacturer?: No
• 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 CRICUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 70