MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Philips received a complaint by the customer on the v60 indicating that when the oxygen concentration test was set 30%, the measured value was 35.3% against the allowable rage which was between 25% and 35%.It was reported there was no patient involvement at the time the issue was discovered.The manufacturer's product support engineer (pse) evaluated the device and confirmed the reported problem.The pse replaced the flow sensor assembly to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.A similar evaluation was performed for the faulty flow sensor assembly.The root cause was identified to be the component u1 designator on the o2 or airflow sensor printed circuit board assembly (pcba).The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

H10: the removed flow sensor assembly was returned to the product investigation lab (pil).The pil technician installed the flow sensor assembly into a pil ventilator to duplicate the reported issue.Visual inspection of the flow sensor assembly revealed no evidence of damage or contamination.The flow sensor assembly was tested, the failure was confirmed.The pil found that flow sensor assembly failed o2 mix accuracy testing for the 30% oxygen setting.The 35% o2 mix result that was taken during testing for the 30% o2 setting was found to be high and out of spec.This is due to a faulty out of spec u1 flow sensor on the printed circuit assembly (pca) portion of the o2 flow module.U1 flow sensor has drifted out of spec.

• Brand Name: RESPIRONICS
• Type of Device: 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: 15764450
• MDR Text Key: 306783250
• Report Number: 2031642-2022-02809
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: Health Professional
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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