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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

E1: reporting institution phone number: (b)(6).Reporter phone number:(b)(6).

Event Description

Philips received a complaint by the customer on the v60 reporting that while the ventilator was in use, the tidal volume suddenly reached zero, the machine alarmed, and subsequently could not be used.It was reported that the device was in use at the time of event; however, it was confirmed that the device was swapped with another and that there was no harm to the patient.The manufacturer's product support engineer (pse) evaluated the device and confirmed the reported problem.The pse replaced the gas delivery system (gds) to resolve the reported issue.It was determined that the gds was the cause of the reported issue.The device passed required performance verification tests per philips standards and was returned to service.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: 18056195
• MDR Text Key: 327174628
• Report Number: 2518422-2023-28616
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 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: 11/02/2023
• 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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Date Device Manufactured: 02/15/2018
• 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