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

Model Number V60 PLUS VENTILATOR, US

Device Problems Inadequate User Interface (2958); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device is freezing.However, he is unable to find an issue.Request checkout as unit is under warranty.It was reported there was no patient involvement at the time the issue was discovered.The investigation is ongoing.

Manufacturer Narrative

H10: per the field service engineer (fse), it was reported that the touchscreen was replaced and the issue was resolved.The system meets the specification for the performed service and is returned to use.

Manufacturer Narrative

A touchscreen was returned for analysis.An investigation was performed, and the product analysis technician reported that the touchscreen operates as designed and resistance measurements passed.The touchscreen calibration test was performed and passed.The touchscreen functions as designed.

• 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: 15765425
• MDR Text Key: 307070059
• Report Number: 2031642-2022-02798
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838090996
• UDI-Public: (01)00884838090996
• 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 Operator: Health Professional
• Device Model Number: V60 PLUS VENTILATOR, US
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/10/2022; 10/21/2023
• Supplement Dates FDA Received: 12/01/2022; 10/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2021
• 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