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

Model Number V60 V60PLUS VENTILATOR

Device Problem Volume Accuracy Problem (1675)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

E1: reporting institution name: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Event Description

Philips received a complaint by the customer on the v60, indicating that the tidal volume could not be displayed due to a patient circuit leakage.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The authorized service provider (asp) engineer confirmed that after the device was turned on, the tidal volume could not be displayed--after reconnecting the power cord, the device turned on, but the fault remained.The asp engineer found that the patient circuit leaked, replaced the patient circuit, and verified that the issue was resolved.The device passed required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: 17000120
• MDR Text Key: 315920968
• Report Number: 2518422-2023-12101
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Date Device Manufactured: 03/25/2021
• 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