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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Contact office phone: (b)(6).

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that a ¿proximal pressure sensor autozero failed¿ error occurred.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.The biomedical engineer (bme) called technical support to report that a ¿proximal pressure sensor autozero failed¿ error occurred.

Manufacturer Narrative

H10: per good faith effort (gfe) response, there was no patient involvement at the time the issue was discovered.The issue has not been resolved yet as the repair is still pending.

Manufacturer Narrative

H10: the biomedical engineer (bme) called technical support to report that a ¿proximal pressure sensor autozero failed¿ error occurred.Multiple attempts have been made to try to obtain further information about this case, but no response was received from the bme.This file is closed and can be reopened if new information becomes available.

• 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: 19074128
• MDR Text Key: 339995817
• Report Number: 2518422-2024-18412
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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,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 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: 03/25/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 05/15/2024
• Supplement Dates FDA Received: 04/12/2024; 05/16/2024
• Date Device Manufactured: 05/20/2014
• 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