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

Model Number V60

Device Problem No Display/Image (1183)

Patient Problem Dyspnea (1816)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Philips received a complaint by the customer on the v60 indicating that the screen suddenly went black.The device was in use on a patient at the time the reported issue was discovered.The impact to the patient is reported as inability to ventilate properly.The patient was experiencing severe pneumonia when the ventilator failed.The patient had to be manually ventilated with a respiratory bag due to the oxygen saturation being 86%.The patient was also short of breath and showed irritability, which immediately prompted the coordination of being placed on a replacement ventilator.The patient's oxygen saturation parameters were closely monitored and was later determined to be at 95% on (b)(6) 2023.Investigation ongoing.

Manufacturer Narrative

H10: the field service engineer restarted the ventilator to resolve the reported issue, no parts replaced.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.Request for additional information conducted, however response was asku.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: 18173769
• MDR Text Key: 328567212
• Report Number: 2518422-2023-31150
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/10/2023
• Date Device Manufactured: 05/10/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention