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

Model Number V60 V60PLUS VENTILATOR

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the gas delivery system (gds) was not working, and the outputs were out of range.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that the gas delivery system (gds) was not working.Per previous good faith effort (gfe) response, the outputs were out of range.

Manufacturer Narrative

H11: an authorized service provider (asp) was dispatched onsite to evaluate and repair the device.Upon arrival, the asp confirmed the reported issue after finding that the gas delivery system (gds) was damaged, and the air flow sensor, oxygen (o2) flow sensor, and o2 mix tests were out of range.Based on this information, this is not a reportable event, and therefore this complaint no longer meets reportability requirements.

• 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: 18845771
• MDR Text Key: 337011229
• Report Number: 2518422-2024-12056
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 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: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/18/2024
• Date Device Manufactured: 08/16/2019
• 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