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

Model Number V60

Device Problem Excessive Heating (4030)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the biomedical engineer (bme) on the v60 ventilator indicating that a 1122 "blower temperature high" error occurred.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.There was not any adverse outcome to patient care or therapy.The bme replaced the air inlet filter and tested the device for approximately 8 hours.The customer advised they were unable to reproduce diagnostic code 1122 - blower temperature high.No further action is required at this time.If additional information is received, the complaint file will be reopened, and a supplemental report will be submitted.

Manufacturer Narrative

H10: g - contact office phone number: (b)(4).

• 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: 19097589
• MDR Text Key: 340253853
• Report Number: 2518422-2024-19108
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 04/01/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 08/10/2011
• 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