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

Model Number V60

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

E1 reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Event Description

Philips received a complaint from the customer on the v60 indicating that while performing preventative maintenance, it was observed that the device had a dim display.It was reported there was no patient involvement at the time the issue was discovered.There was no patient or user harmed.

Manufacturer Narrative

It was confirmed that due to the delay of the pending backorder user interface assembly replacement, the customer decided to decline repair.The device has been returned unrepaired to the customer.The investigation concludes that no further action is required at this time.The device remains at the customer site.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philips' normal complaint procedure.

Manufacturer Narrative

The authorized service provider (asp) evaluated the device and confirmed the reported problem.There is no problem in reading the display contents, but the brightness of the screen is low.It was confirmed that it has decreased.For improvement, replacing the user interface assembly is required.

• 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: 18540173
• MDR Text Key: 333215889
• Report Number: 2518422-2024-03430
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: Other
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 02/06/2024
• Supplement Dates FDA Received: 02/06/2024; 02/14/2024
• Date Device Manufactured: 07/19/2011
• 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