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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that while the device was in use on a patient, the display screen went blank.The device was removed from the patient without incident.No patient or user harm was reported.The customer called technical support to report that while the device was in use on a patient, the display screen went blank-- although the device continued to operate and cycle breaths, no parameters were visible; however, alarms were not activated, and the touchscreen remained operational.The biomedical engineer (bme) confirmed the reported issue and found that the issue was possibly due to the fact that the customer had the original first-generation liquid crystal display (lcd) installed.The remote service engineer (rse) advised the customer to replace the user interface (ui) display assembly with the second-generation lcd to correct the issue and provided the customer with the part number and price of the replacement ui assembly for repair.The investigation is ongoing.
Additional Manufacturer Narrative
Per good faith effort (gfe) response received 21sep2024, the field service technician checked the connections for the display and checked with another device to confirm that the screen was the issue.The field service technician ultimately ordered the replacement user interface (ui) assembly, and upon receiving the new part, the field service technician performed the replacement and verified that the issue was resolved.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
• Common Device Name: 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: 20246576
• Report Number: 2518422-2024-59153
• Device Sequence Number: 7301180
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/21/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 06/08/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown