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

Model Number V60 V60PLUS VENTILATOR

Device Problem Display Difficult to Read (1181)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the devices backlight was dim.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed that the backlight no longer works.Setting to 5 the screen brightness was as if it were set to 1.On the other hand, the on/off button light-emitting diode (led) was dim at orange level.The rse sent a proposal for a user interface (ui) assembly.

Manufacturer Narrative

E1: reporting address state: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).G1: contact office phone: (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: 19165334
• MDR Text Key: 340847067
• Report Number: 2518422-2024-21682
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: 00884838009868
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 09/26/2014
• 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