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

Model Number V60

Device Problem Failure to Read Input Signal (1581)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there was an spi bus failure.The device was reported to be outside of use at the time of the reported problem.No patient harm reported.The field service engineer (fse) attempted to replace the power management (pm) printed circuit board assembly (pcba) on 18sep2023 as a troubleshooting measure, but the issue did not resolve.The fse reinstalled the old pm pcba back into the unit.It was stated by the fse that the customer would likely handle the repair of the device on their own but wanted a quote from philips for the replacement parts and onsite labor.Investigation is ongoing.

Manufacturer Narrative

On 13oct2023, the field service engineer (fse) completed a customer service report, and it showed that the device now passed all testing.The fse replaced the motor controller (mc) printed circuit board assembly (pcba) and returned an unused data acquisition (da) pcba.In a good faith effort (gfe) response from the field service engineer (fse) received on 19oct2023, it was confirmed that the motor controller (mc) printed circuit board assembly (pcba) was the only part replaced to resolve the device issue and the device was returned to use.The investigation concludes that no further action is required at this time.If additional 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: 17847180
• MDR Text Key: 324630593
• Report Number: 2518422-2023-25059
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2023

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?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• 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