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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Emits Odor (1425)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a power board that had malfunctioned.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a power board that had malfunctioned.The customer stated that the power management (pm) printed circuit board assembly (pcba) had a burning smell due to a possible component damage when the device was being turned on.The rse noted that the pm board required replacement.A philips service engineer (se) reported that the pm board was replaced, and the device successfully passed all the required performance tests.The device was returned to service.

• 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: 17595894
• MDR Text Key: 321678391
• Report Number: 2518422-2023-20405
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,User Facility
• 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: 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: 08/14/2023
• Initial Date FDA Received: 08/22/2023
• Date Device Manufactured: 09/22/2021
• 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