MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Decrease in Pressure (1490)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer on the v60 indicating that the device is getting a low oxygen inlet pressure alarm sounded when the unit was being used by the patient.The unit kept operating when the alarm occurred.There was neither a delay in therapy nor medical intervention reported other than the ventilator swap.The manufacturer's product support engineer (pse) evaluated the device and confirmed the reported problem.The customer disconnected and reconnected the piping, but the issue was not resolved.The investigation is ongoing.

Manufacturer Narrative

E1: reporting institution phone: (b)(6).Reporter phone number: (b)(6).

Manufacturer Narrative

Further troubleshooting was performed and the reported phenomenon was not duplicated.In the event log, "oxygen not available" alarm (diagnostic code 1208) and "check vent: oxygen device failed" alarm (diagnostic code 1111) had been recorded.However, any special anomaly was not found.These alarms could occur in case a leak volume steeply increased at the time of using high-pressure oxygen.The device was confirmed to be operating per specifications and no failure was identified.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: 17788990
• MDR Text Key: 323931611
• Report Number: 2518422-2023-24020
• Device Sequence Number: 1
• Product Code: MNT
• 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,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 Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/12/2023
• Date Device Manufactured: 02/15/2019
• 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