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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contact office phone: (b)(6).
Event or Problem Description
Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that the blower motor was not working.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that the blower motor was not working and requested assistance with troubleshooting.The blower was connected to the motor controller (mc) printed circuit board assembly (pcba) and showed 3000 rpm in pneumatics, but there was no output.The remote service engineer (rse) advised the bme to either swap the mc pcba for troubleshooting and replace it if needed or replace the blower assembly.
Additional Manufacturer Narrative
H10: multiple attempts have been made on 26apr2024, 04may2024, and 15may2024 to try to obtain further information about this case, but no response was received from the customer.This file is closed and can be reopened if new information becomes available.

• Brand Name: RESPIRONICS
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19127795
• Report Number: 2518422-2024-20416
• Device Sequence Number: 8283774
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: 00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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
• Operator of Device: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/28/2024
• Date Device Manufactured: 05/07/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown