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 01/12/2023

Event Type  malfunction  

Event Description

This report is based on information provided by philips remote service personnel and is being investigated by the philips complaint handling team.Philips received a complaint on the v60 ventilator indicating that there was a 100b (watchdog test failed) error code.The device was reported to be outside of use at the time of the reported problem.No patient/user harm reported.The customer biomedical engineer (bme) reported to the philips remote service engineer (rse) that there was a 100b diagnostic code.The watchdog timer was not strobed as expected with 8-ms and a 12-ms window.It was reported to have occurred during a performance verification test (pvt).The customer stated that they replaced the cpu pcba and wanted to restore the serial number.The customer stated that they would call back for remote technical support with the new cpu serial number to obtain purchase options for the device software.Resolution confirmation is pending the customer callback for further remote service.This investigation is ongoing.

Manufacturer Narrative

H10:the remote service engineer (rse) received update from customer biomedical engineer (bme) confirming that the replacement cpu board resolved the initial 100b watchdog issue and the option code restoration was successful.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H11: updated contact information, contact office entity, and manufacturing site.

Manufacturer Narrative

This report is being submitted as a correction in response to corrective actions taken by the legal manufacturer.The manufacturer site number was incorrectly selected resulting in incorrect report numbers.A new mdr with the correct manufacturer site selected has been submitted under manufacturer report # 2518422-2023-18034.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16330288
• MDR Text Key: 309123420
• Report Number: 2031642-2023-00443
• 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: Biomedical Engineer
• 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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/02/2023; 02/02/2023
• Supplement Dates FDA Received: 02/28/2023; 08/03/2023
• Date Device Manufactured: 01/26/2013
• 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