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

Model Number V60 V60PLUS VENTILATOR

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 indicating that a 111d "motor controller (mc) printed circuit board assembly (pcba) analog to digital converter (adc) failed" error occurred.It was reported that there was no patient involvement at the time the issue was discovered.The customer initially called to technical support to report that when attempting to use the device on a patient, the 111b "35v supply failed" and 1118 "5v supply failed" alarm errors occurred.The manufacturer's product support engineer (pse) evaluated the device and after confirming the reported issue, the pse also discovered that a 111d "mc pcba adc failed" error occurred.The pse found that the cause was due to a failure in the motor controller (mc) printed circuit board assembly (pcba) and stated that the mc pcba needed to be replaced.The investigation is ongoing.

Manufacturer Narrative

H10: the technician found that the cause was due to a failure in the motor controller (mc) printed circuit board assembly (pcba).According to the technician, the error will be resolved by replacing the mc pcba.Based on the service manual, the replacement mc pcba should resolve the issue.The investigation concludes that no further action is required at this time.If additional case 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: 18639960
• MDR Text Key: 334537155
• Report Number: 2518422-2024-05747
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 08/14/2017
• 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