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

Model Number V60

Device Problem Date/Time-Related Software Problem (2582)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating a watchdog failure.It was reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer stated they were getting error code 100b (watchdog test failed) after replacing the flow sensor assembly.The rse performed a troubleshoot with the customer and the customer then requested the part number for the replacement central processing unit (cpu) and motor control (mc) board.

Manufacturer Narrative

Multiple attempts have been made to try to obtain further information about this case but no response received from the customer.This file is closed and can be reopened if new information becomes available.

• 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: 16573846
• MDR Text Key: 311851233
• Report Number: 2518422-2023-07247
• 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,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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 05/18/2023
• Date Device Manufactured: 02/08/2016
• 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