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

Model Number V60

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Philips received a complaint from customer biomed, reporting the v60 ventilator was alarming with high flow therapy (hft).The device was in clinical use.The unit was exchanged for another v60 ventilator to continue therapy.There was no harm resulting.A philips remote service engineer (rse) evaluated the issue with biomed and reported review of diagnostic log report identified multiple occurrences of error code 122d (alarm message: cannot reach target flow).The rse advised review of the circuit used to ensure no flow restrictions and a successful performance verification test (pvt) prior to returning to service.

Manufacturer Narrative

H10: the final disposition of the device could not be confirmed because the customer did not respond to requests for additional information.Multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on (b)(6) 2023, (b)(6) 2023 and (b)(6) 2023, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• 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: 16597470
• MDR Text Key: 311873459
• Report Number: 2518422-2023-07579
• 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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/27/2023
• Date Device Manufactured: 12/07/2011
• 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