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 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

H11: g1 phone number (b)(6).

Event Description

Philips received a complaint on the v60 ventilator indicating that the screen was very dim and adjustments to the brightness did not help.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.The customer informed the remote service engineer (rse) of the issue and requested the part numbers required for a repair.The rse provided the customer with the part information for the 2nd generation liquid crystal display (lcd), 2nd generation lcd cable, 2nd generation user interface (ui) printed circuit board assembly (pcba), lcd to ui pcba cable, 2nd generation lcd tray, and screw pack.This investigation is ongoing.

Manufacturer Narrative

The customer informed the remote service engineer (rse) of the issue and requested the part numbers required for a repair.The rse provided the customer with the part information for the 2nd generation liquid crystal display (lcd), 2nd generation lcd cable, 2nd generation user interface (ui) printed circuit board assembly (pcba), lcd to ui pcba cable, 2nd generation lcd tray, and screw pack.Multiple good faith efforts (gfe) were attempted to obtain confirmation of the part order, part replacement, and resolution.No response or further information was received from the customer.The investigation concludes that no further action is required at this time.

• 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: 19059810
• MDR Text Key: 339617315
• Report Number: 2518422-2024-17966
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• Date Device Manufactured: 12/17/2009
• 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