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

Model Number V60

Device Problem Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was not ventilating.The patient presented with pre-existing and underlying conditions of copd (chronic obstructive pulmonary disease), audible wheezing, and hypoxia as evidenced by an arterial blood gas.The v60 ventilator was turned on and the patient was placed onto the ventilator for assisted breathing.It was noted that the patient's breathing could not trigger the device appropriately.It was alleged that no improvement to the pre-existing conditions occurred, prolonging treatment time and increasing patient pain.The v60 ventilator is a bilevel positive pressure device that is reliant upon a spontaneously breathing patient's ability to trigger a breath to effectively provide bilevel ventilation for respiratory and ventilatory support.Currently, no cause and/or contribution to the patient pre-existing conditions has been illustrated in the complaint.Further information regarding this event will be requested.

Manufacturer Narrative

H10 g - (b)(6).

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19084026
• MDR Text Key: 339859575
• Report Number: 2518422-2024-18867
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Date Device Manufactured: 11/03/2012
• 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