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

Model Number V60 V60PLUS VENTILATOR

Device Problem Excessive Heating (4030)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

Philips received a complaint from a philips authorized service provider (asp) reporting a high blower temperature error occurred on the v60 ventilator.The issue was identified during a service event.Device use at the time the issue occurred is unknown.There was no report of harm, or patient impact.A philips authorized service provider (asp) evaluated the device which included a review of the device event log prior to performing mandatory field correction order activities.The asp identified two occurrences of diagnostic code 1122, indicating the blower temperature was greater than 95 degrees for longer than sixty seconds.The asp advised the customer and a service proposal for repair was issued.The investigation is ongoing.

Manufacturer Narrative

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Manufacturer Narrative

A philips authorized service provider (asp) evaluated the device which included a review of the device event log prior to performing mandatory field correction order activities.The asp identified two occurrences of diagnostic code 1122-high blower temperature error, indicating the blower temperature was greater than 95 degrees for longer than sixty seconds.The asp advised the customer and a service proposal for repair was issued.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19110486
• MDR Text Key: 340365830
• Report Number: 2518422-2024-19674
• 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,User Facility
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/09/2024
• Date Device Manufactured: 09/06/2013
• 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