MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; V60-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 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The user is reporting they received a flow sensor but it was failing out of box.There is no patient involvement.

Manufacturer Narrative

H10: philips received a complaint by the customer on the v60 indicating that the purchased flow sensor assembly was an out of box failure as it generated a 100b "watchdog test failed" error code.It was reported that there was no patient involvement at the time the issue was discovered.The customer reported to the remote service engineer (rse) that the purchased flow sensor assembly was an out of box failure as it generated a 100b "watchdog test failed" error code in 2 different v60 devices during installation.The rse transferred the customer to parts for a warranty replacement.Multiple attempts have been made 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
• Type of Device: V60-VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 16077643
• MDR Text Key: 307306675
• Report Number: 2031642-2022-03278
• 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 Health Care Professional
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2017
• 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