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 Dyspnea (1816); Encephalopathy (1833); High Blood Pressure/ Hypertension (1908); Septic Shock (2068); Hypoxia in Utero (2210); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484); Lethargy (2560); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/10/2020

Event Type  Death  

Event Description

Philips received notification of a voluntary medwatch report # mw5105082 stating that a patient had expired during clinical and therapeutic use of the v60 ventilator on (b)(6)2020.The decedents next of kin alleges poor data quality to have caused and/or contributed to the patient expiration.Based upon the information provided within #mw5105082, it is unclear if the allegation is being lodged against the v60 ventilator or the trilogy 100 ventilator.Based upon the information provided by the decedents next of kin, the patient had been receiving therapy for approximately six months via a philips respironics trilogy 100.The patient experienced shortness of breath and lethargy resulting in hospitalization.It was noted that approximately four to five times over an unspecified period of time the patient had been hospitalized.Previous diagnoses include: chronic and acute respiratory failure with hypoxia and hypercapnia, congestive heart failure, copd (unspecified), chronic hypertension, acute encephalopathy, and septic shock.Concomitant medications have been listed as: benzonatate 100 mg, cefdinir 300 mg, prednisone 20mg, albuterol 2.5 mg ,tama escitalopr.Am oxalate 10mg, gabapentin 300 mgs,lisinopril 10- 12.5 mg, ondansetron 10 mgs, umeclidinium- vilanterol 62.5-25 mcg/actuation inhaler.Further information regarding patient expiration, cause of death, and event context have not been divulged to philips.

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: 12973418
• MDR Text Key: 282029956
• Report Number: 2031642-2021-05732
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/15/2022
• 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