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

Model Number V60 V60PLUS VENTILATOR

Device Problem Insufficient Information (3190)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device was not working.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.The biomedical engineer (bme) called technical support to report that the device was not working.The investigation is ongoing.

Manufacturer Narrative

The bme ordered the data acquisition (da) printed circuit board assembly (pcba), and after performing the da pcba replacement, the bme tested the device and placed the device back in service.Multiple attempts have been made to try to obtain further information about this case, but no response was received from the bme.It is unknown what the reported issue was, and no further information could be obtained.

Manufacturer Narrative

The biomedical engineer (bme) called technical support to report that the device was not working.The bme performed troubleshooting, and nothing was observed.Multiple attempts have been made to try to obtain further information about this case, but no response was received from the bme.

• 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: 18519781
• MDR Text Key: 333003072
• Report Number: 2518422-2024-02676
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/02/2024; 02/14/2024
• Supplement Dates FDA Received: 02/05/2024; 03/12/2024
• Date Device Manufactured: 11/17/2020
• 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