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 06/27/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that after replacing the flow sensor assembly, error code 100b watchdog test failed message appeared.It was reported there was no patient involvement at the time the issue was discovered.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed that the flow sensor assembly was defective on arrival (defoa).After replacing air and o2 flow sensor assembly per service guide instructions, device errors out into black screen "watchdog test failed" error code 100b.Reinstalled old assembly, powered on into normal ventilation mode with no errors.Defective flow sensor assembly.Re-ordering part.Repair cannot be completed with delivered part.Further work required.Device not returned to use, and the investigation is ongoing.

Manufacturer Narrative

H10: as it was confirmed after reinstalling the old flow sensor assembly, the "watchdog test failed" error code 100b disappeared and the device powered on into normal ventilation mode.The new flow sensor was ordered and once it is received and replaced, the device will be put back into service.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: 17350472
• MDR Text Key: 319308892
• Report Number: 2518422-2023-16175
• Device Sequence Number: 1
• Product Code: MNT
• 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: User Facility
• Reporter Occupation: Other
• 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: Other
• 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: 06/27/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/18/2023
• Date Device Manufactured: 10/31/2014
• 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