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 03/13/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that a "proximal pressure sensor autozero failed" error occurred.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that a "proximal pressure sensor autozero failed" error occurred, and the error code was confirmed in the event log.The remote service engineer (rse) performed troubleshooting with the customer, and the customer confirmed alignment of the data acquisition (da) printed circuit board assembly (pcba).The rse provided the customer with the part number of the solenoids and da pcba for repair.Per good faith effort (gfe) response, the customer stated that the solenoids were ultimately ordered for repair/replacement.Upon receiving the solenoids, the customer 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
• 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: 19015084
• MDR Text Key: 339060864
• Report Number: 2518422-2024-16626
• 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
• 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
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 12/10/2020
• 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