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

Model Number V60 V60PLUS VENTILATOR

Device Problem Gas/Air Leak (2946)

Patient Problems Dyspnea (1816); Hypoxia (1918)

Event Date 03/18/2024

Event Type  Injury  

Event Description

Philips received a complaint by the customer on the v60, indicating that during clinical and therapeutic use of the v60 ventilator, a patient with an acute exacerbation of chronic obstructive pulmonary disease (copd) experienced a desaturation of peripheral oxygenation (spo2) from 98% to as low as 85%-- the device alarmed that the blood oxygen saturation was as low as 85% and was progressively decreasing.The device was found to have a broken and leaking breathing circuit that was causing the decrease to patient spo2.The breathing circuit was immediately replaced, and the oxygen concentration of the ventilator was adjusted.After treatment, the patient's blood oxygen saturation reached 98%, and the patient's vital signs were stable.The customer called technical support to report that during clinical and therapeutic use of the v60 ventilator, a patient with an acute exacerbation of chronic obstructive pulmonary disease (copd) experienced a desaturation of peripheral oxygenation (spo2) from 98% to as low as 85%-- the device alarmed that the blood oxygen saturation was as low as 85% and was progressively decreasing.The device was found to have a broken and leaking breathing circuit that was causing the decrease to patient spo2.The breathing circuit was immediately replaced, and the oxygen concentration of the ventilator was adjusted.After treatment, the patient's blood oxygen saturation reached 98%, and the patient's vital signs were stable.

Manufacturer Narrative

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

Manufacturer Narrative

H10: per good faith effort (gfe) response received on 28mar2024, the authorized service provider (asp) engineer stated that the issue was confirmed as the patient circuit was found to be broken-- the hospital equipment department therefore ordered the replacement patient circuit for repair, and upon receiving the new patient circuit, the hospital equipment department performed the replacement to resolve the issue.The cause of the issue was due to a user error as the patient circuit was not checked per the user manual prior to use.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: 19002995
• MDR Text Key: 338890649
• Report Number: 2518422-2024-16089
• 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: 03/21/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/04/2024
• 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