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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Philips received a complaint from customer biomed, reporting the v60 ventilator would not go into standby mode.The device was not in clinical use.There was no report of harm, and no impact to patient, nor user.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and reported the average air standard liters per minute (slpm) readout on the pneumatics screen was -2.5.The rse informed the bme the reading was out of tolerance and advised full performance verification testing to diagnose the issue.

Manufacturer Narrative

H10: air flow sensor assembly was recommended for replacement.The customer confirmed the part has not been made available for device repair.The repair for this unit cannot be conducted at this time due to the part(s) being on backorder.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered (air flow sensor assembly) aligns with the recommended repair of the alleged malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

• 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: 18334547
• MDR Text Key: 330596491
• Report Number: 2518422-2023-35820
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Date Device Manufactured: 09/13/2011
• 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