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

Model Number V60 V60PLUS VENTILATOR

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Philips received a complaint from a customer biomed, reporting a check vent condition occurred on the v60 ventilator indicating the oxygen (o2) was out of range.The device was not in clinical use.There was no report of harm.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and confirmed the reported issue.The bme attempted to zero the calibrate the flow sensor.The rse advised to re-try the calibration.

Manufacturer Narrative

H10: the remote service engineer (rse) reported the biomed engineer (bme) called back and reported the issue was resolved with replacement of the flow sensor.Multiple attempts were made on (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023, to try to obtain further details about this case, but no response received from the customer.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: 17953965
• MDR Text Key: 325927179
• Report Number: 2518422-2023-27021
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/08/2023
• Date Device Manufactured: 09/18/2013
• 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