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 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

E1: reporting address postal: (b)(6), reporting institution phone reporter phone , g1 contact office phone.

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a proximal pressure sensor auto-zero failed alarm.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.The customer stated that the device continued to operate when the alarm occurred.The device was then replaced with another v60 ventilator.There was no delay in therapy or medical intervention required as a result of the device issue.The customer chose to not disclose the patient information from the time of the event.This investigation is ongoing.

Manufacturer Narrative

H10: on 19apr2024, an authorized service provider (asp) inspected the device and confirmed the proximal pressure sensor auto-zero failed error code in the device event log.Because the error code was confirmed, the asp replaced the data acquisition (da) printed circuit board assembly (pcba) as a preventative measure.Following the repair of the device the asp completed a cleaning, running test, and function test of the device.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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19080876
• MDR Text Key: 340113175
• Report Number: 2518422-2024-18748
• 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

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/22/2024
• Date Device Manufactured: 06/16/2020
• 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