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

Model Number V60

Device Problems Failure to Calibrate (2440); Communication or Transmission Problem (2896)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

E1 reporter phone number (b)(6).

Event Description

Philips received a complaint by the customer on the v60 indicating that during routine maintenance at bench repair, a 111d check vent: motor controller (mc) printed circuit board assembly (pcba) adc failed alarm error occurred when the device was turned on.It was reported that there was no patient involvement at the time the issue was discovered.Per previous gfe response, the field service engineer (fse) confirmed that the power management board and motor controller board were both malfunctioning and caused the ventilator to display a slew of warnings on the screen.A service quote for the repair has been sent to the customer for approval.

Manufacturer Narrative

H10: the customer accepted the service proposal, and the field service engineer (fse) replaced the power management (pm) board and motor controller (mc) board.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.If additional information is received, the complaint file will be reopened.

Manufacturer Narrative

H10 philips investigation lab confirmed that the check vent: mc pcba adc failed (ec 111d) and other alarms were triggered due to motor controller pcba analog to digital converter circuit having failed.

• 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: 17388946
• MDR Text Key: 319765854
• Report Number: 2518422-2023-16687
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup

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
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 05/16/2024
• Supplement Dates FDA Received: 08/03/2023; 05/17/2024
• Date Device Manufactured: 07/30/2015
• 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