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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Philips received a complaint from a philips authorized service provider (asp) indicating that diagnostic code 110b - proximal pressure sensor autozero failed occurred on the v60 ventilator.Device usage at the time of the event is unknown.The asp found the issue while reviewing the device event log.There was no report of harm.No patient or user impact was reported.The device did not meet specification for intended use and remained out of service.

Manufacturer Narrative

Upon further investigation, this complaint is determined to be a duplicate of the same issue reported under mdr number 2518422-2023-11084.Therefore, this report is being redacted.All investigation and reporting activities will be performed and documented in the complaint reported in mdr number 2518422-2023-11084.

• 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: 18753972
• MDR Text Key: 335937161
• Report Number: 2518422-2024-09048
• 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,Company Representative
• 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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/19/2024
• Date Device Manufactured: 05/23/2017
• 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