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

Model Number V60

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Dyspnea (1816); Pain (1994); Pneumonia (2011); Ventilator Dependent (2395); Aspiration Pneumonitis (4455)

Event Date 08/21/2021

Event Type  Death  

Event Description

Philips received notification of a voluntary medwatch report # mw5105083 stating that a patient had expired during clinical and therapeutic use.Based upon the information provided by the decedents surviving spouse, the patient experienced shortness of breath and was located within a critical care unit.X-rays were conducted and it was reported that the patient had experienced bacterial and aspiration pneumonia.The patient was placed onto antibiotics and medication for pain management, however the following morning breathing problems were noted to have worsened.The patient was placed onto a v60 ventilator (settings, configuration unspecified) for comfort.The patient was reported to have been breathing comfortably, however later in the evening the patient again experienced difficulty breathing.The respiratory therapist on shift was reported to have increased the delivered fio2 to accommodate the patients needs and the attending physician suggested administration of morphine (dosage unspecified) for pain management.At approximately 0300 the following morning further adjustments were made to the ventilator by the respiratory therapist.Approximately 30 minutes after adjustments were made to the ventilator, the device was reported to have emitted a loud buzzing noise and the patient was no longer breathing.Immediately thereafter the reporter states that he asked a secondary respiratory therapist what was done to the device by the previous respiratory therapist, to which he was informed that the fio2 was decreased.The reporter asked the respiratory therapist why his spouse was placed onto a v60 ventilator that had been recalled, to which the reported response was the respiratory therapist educating the reporter that a particular part was recalled and not currently in use.Photos of the alleged recalled part were not provided within voluntary medwatch report # mw5105083.

Manufacturer Narrative

Due to absence of information regarding device serial number and institution of clinical use, further investigation into device evaluation, resolution, conclusion and root cause cannot be further conducted.A complaint record of the allegation and event shall be cataloged within philips complaint handling database.Should further information be provided at a future date, the complaint record shall be amended with appropriate follow-up reporting to competent authorities conducted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12977676
• MDR Text Key: 282069276
• Report Number: 2031642-2021-05733
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/26/2022
• 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
• Patient Outcome(s): Death