MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Deliver (2338)

Patient Problems Dyspnea (1816); Hypoxia (1918)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

E1: reporting institution name: (b)(6).Reporter phone #: (b)(6).

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a respiratory line that was broken and was leaking.The device was in clinical use when the issue occurred.It was reported that the patient had a type ii respiratory failure, when they were admitted to the clinical department; it was reported that their blood oxygen saturation was monitored at 85% upon admission.The clinical doctors used a ventilator to provide respiratory support to the patient, and the blood oxygen saturation was monitored, and reached 98%.It was then reported that after one hour, the ventilator alarm and the monitor alarm showed a low blood oxygen saturation, causing the patient's blood oxygen saturation to decrease to 78% and gradually decrease.The patient's shortness of breath significantly intensified, and upon investigation, it was found that the respiratory line was broken and leaking.It was determined that malfunction caused the patient's blood oxygen saturation to decrease to 78% and gradually decrease.The patient was immediately replaced with a new respiratory line and the ventilator oxygen pressure was adjusted.After treatment, the patient's blood oxygen saturation increased to 98%, and their vital signs stabilized.

Manufacturer Narrative

H10: a follow up was performed with the key market, and the responder reported that the hospital's equipment department replaced the breathing pipe to resolve the issue.The device was returned to service.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18958716
• MDR Text Key: 338350492
• Report Number: 2518422-2024-14851
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/05/2024
• 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): Required Intervention