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

Model Number V60

Device Problems Failure to Read Input Signal (1581); Device Sensing Problem (2917)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

This report is based on information provided by philips service personnel and has been investigated by the philips complaint handling team.Philips received a complaint from customer, reporting that the v60 ventilator would not go into standby mode.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) reported that the customers device does not stay in standby mode when prompted during set up.It was reported that the pneumatics screen avg air display shows a -1.2 lpm when set to zero; this was determined to be out of specification.It was noted that the device had recently had the preventative maintenance performed.The rse advised the customer that flow sensors would need to be replaced to correct the issue.The customer was provided with the part id for flow sensor assembly, air, and o2.

Manufacturer Narrative

H10: insufficient information is available to determine the resolution of the event.The customer was provided with parts id; however, it could not be confirmed if the customer replaced the specified parts.Multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on 12/06/2022, 12/20/2022 and 01/10/2023, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• 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: 16019464
• MDR Text Key: 307681371
• Report Number: 2031642-2022-03174
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/25/2023
• Date Device Manufactured: 07/06/2011
• 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